IMPEDE-FX Embolization Plug IMP-FX-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00810041650054), received between Nov 18, 2022 and Mar 2, 2026 — classified as 5 deaths, 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (16 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Migration

  AN EVAR WITH A TYPE II ENDOLEAK WAS BEING TREATED. A 6FR MPA1X125CM CORDIS VISTA BRITE TIP GUIDING CATHETER WAS USED TO DEPLOY THREE (3) IMP-FX-12 DEVICES. ACCESS TO THE SAC WAS OBTAINED USING LASER FENESTRATION VIA THE RIGHT LIMB. THE FIRST TWO PLUGS DEPLOYED WITHOUT INCIDENT. THE THIRD PLUG, WHICH WAS DEPLOYED NO DIFFERENTLY WITH THE GUIDE CATHETER IN THE SAME POSITION, EXITED THE SAC AND TRAVELED UP THE CAVA TO THE PULMONARY ARTERY. A PULMONOLOGIST CAME INTO THE ROOM AND ASSESSED THE PLUG'S LOCATION AND DETERMINED THERE WAS NO CLINICAL SEQUELAE AND THEREFORE LEFT THE PLUG TO STAY. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO LUNG ISSUES. THE FOLLOWING INDIVIDUALS WERE PRESENT AT THE CASE: (B)(6), SMM (ATTENDING VIRTUALLY WITH VIDEO & AUDIO). (B)(6) (ATTENDING IN-PERSON).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491851 ↗
• MalfunctionFeb 20, 2026Migration

  DURING A PELVIC CONGESTION SYNDROM (PCS) CASE, SIX IMP-FX-12 PLUGS WERE IMPLANTED INTO THE GONADAL VEIN. AFTER THE FINAL TWO WERE PLACED, THE RESULT WAS CONFIRMED WITH CONTRAST AND THREE COOK COILS WERE PLACED AT THE PROXIMAL END. IT WAS THEN REALIZED THAT THE LAST TWO IMP-FX-12 WERE MISSING FROM THE TARGET SITE. INITIALLY, IT WAS THOUGHT THAT THEY HAD MIGRATED DISTALLY (DEEPER INTO THE PELVIC FLOOR). THE PHYSICIAN PROCEEDED TO TREAT THE NUTCRACKER AND MAY-THURNER SYNDROMES, HOWEVER, UPON A FINAL CHECK, IT WAS DISCOVERED THE TWO MISSING IMP-FX-12 IN THE RIGHT PULMONARY ARTERY. THE PATIENT REMAINED STABLE, SO THE DEVICES WERE LEFT IN SITU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408143 ↗
• MalfunctionNov 4, 2025Malposition of Device; Migration; Malposition of Device; Migration

  BASED ON THE INFORMATION PROVIDED, DURING A TRANSCAVAL EMBOLIZATION PROCEDURE FOR TREATMENT OF A TYPE II ENDOLEAK, THE PHYSICIAN ENCOUNTERED SIGNIFICANT ANATOMICAL CHALLENGES IN ACCESSING THE LARGE ANEURYSM SAC, WHICH WAS ADJACENT TO AND PARTIALLY FLATTENED AGAINST THE INFERIOR VENA CAVA (IVC). INITIAL ATTEMPTS USING A 7F × 55 CM TOURGUIDE SHEATH WERE UNSUCCESSFUL DUE TO EXCESSIVE TORQUE AND LIMITED CONTROL SO THE PHYSICIAN SUBSEQUENTLY SWITCHED TO A 6.5F × 45 CM TOURGUIDE SHEATH. A HOT WIRE TECHNIQUE UTILIZING AN ASAHI ASTATO 0.014 GUIDEWIRE AND A BOVIE ELECTROCAUTERY DEVICE WAS USED TO GAIN ACCESS TO THE SAC, ALTHOUGH MANEUVERABILITY REMAINED LIMITED THROUGHOUT THE PROCEDURE. TO ACHIEVE A MORE STABLE WORKING ANGLE, LEFT FEMORAL ACCESS WAS OBTAINED, AND A 14F GORE DRYSEAL SHEATH WITH A 32 CC CODA BALLOON POSITIONED IN THE LEFT COMMON ILIAC VEIN (LCIV) WAS USED AS A BACKSTOP TO STABILIZE THE TOURGUIDE/LAUNCHER SYSTEM FROM THE RIGHT SIDE. THE PHYSICIAN PROCEEDED TO DELIVER A TOTAL OF 90 IMPEDE-FX-12 PLUGS INTO THE ANEURYSM SAC. IMAGING AT THAT STAGE DEMONSTRATED SATISFACTORY FILLING, BUT RESIDUAL CONTRAST WAS VISIBLE AT THE BOTTOM OF THE SAC DUE TO INCOMPLETE EXPANSION OF THE PLUGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460557 ↗
• MalfunctionOct 30, 2025Malposition of Device; Malposition of Device

  ON (B)(6), DURING A PELVIC CONGESTION SYNDROME (PCS) EMBOLIZATION CASE WITH DR. (B)(6), AN IMPEDE-FX-12 PLUG MIGRATED. THE LEFT OVARIAN VEIN WAS ACCESSED VIA THE RIGHT INTERNAL JUGULAR VEIN USING A 6FR 65 CM DESTINATION SHEATH. A NON-SMM COIL WAS PLACED IN THE DISTAL PORTION OF THE OVARIAN VEIN, FOLLOWED PROXIMALLY BY AN IMPEDE-10 PLUG. THREE IMPEDE FX-12 PLUGS WERE THEN PLACED IN THE MORE PROXIMAL SEGMENT OF THE VEIN, WITH THE INTENT TO PLACE AN ADDITIONAL NON-SMM COIL PROXIMALLY TO COMPLETE THE EMBOLIZATION. DURING THIS STEP, THE SHEATH WAS RETRACTED TO THE MOST PROXIMAL PORTION OF THE OVARIAN VEIN, AT WHICH POINT ONE IMPEDE FX-12 MARKER BAND WAS NO LONGER VISIBLE. FLUOROSCOPY OF THE THORAX REVEALED THE IMPEDE FX-12 HAD MIGRATED TO A DISTAL PULMONARY ARTERY BRANCH. RIGHT FEMORAL VENOUS ACCESS WAS OBTAINED, AND THE IMPEDE FX-12 WAS SUCCESSFULLY RETRIEVED USING THE INARI THROMBECTOMY SYSTEM. FINAL ANGIOGRAPHY CONFIRMED GOOD FLOW TO THE AREA AS WELL AS ADEQUATE EMBOLIZATION OF THE LEFT OVARIAN VEIN AND PRESERVED PULMONARY PERFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430156 ↗
• InjuryOct 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTED AAA WITH SHAPE MEMORY PLUGS.

  Patient problems: Unspecified Infection

  MAUDE report 23418151 ↗
• DeathOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT WAS BEING TREATED AT (B)(6) CENTER FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ENDOLEAK IN CONJUNCTION WITH BILATERAL ILIAC BRANCHES TO ADDRESS DISTAL SEAL IN THE ORIGINAL MEDTRONIC ENDURANT STENT GRAFT (MDT ENDURANT). THE AAA EMBOLIZATION OCCURRED FIRST PROCEDURALLY WHERE DR. (B)(6) IMPLANTED 50 IMP-FX-12 PLUGS. THE RIGHT THEN LEFT ILIAC BRANCHES TREATMENT USING GORE DEVICES FOLLOWED AFTERWARDS. AT THE END OF THE PROCEDURE EMBOLIZATION WAS COMPLETE, AND THE PATIENT WAS IN STABLE CONDITION. THE PATIENT REMAINED IN THE HOSPITAL PER NORMAL PROCEDURE, HOWEVER OVERNIGHT (POST-OPERATION) THE PATIENT EXPERIENCED INTRACEREBRAL HEMORRHAGE (ICH) AND EXPIRED. IT WAS REPORTED BY SHAPE MEMORY MEDICAL (SMM) REPRESENTATIVES, (B)(6), WHO WERE NOTIFIED AND COMMUNICATED WITH DR. (B)(6) OF THE ADVERSE EVENT, THAT THE ICH WAS UNRELATED TO THE AAA EMBOLIZATION/SMM DEVICES. DR. (B)(6) STATED THAT, "HE [THE PATIENT] HAD BALLOON ANGIOPLASTY OF HIS AORTIC VALVE TWO DAYS AGO SO PROBABLY HEMORRHAGIC TRANSFORMATION."

  Patient problems: Hemorrhagic Stroke; Intracranial Hemorrhage

  MAUDE report 23344095 ↗
• MalfunctionOct 16, 2025Malposition of Device; Migration; Malposition of Device; Migration

  ON (B)(6) 2025, DURING TREATMENT OF A SMALL (LESS THAN OR EQUAL TO 2 CENTIMETERS, 5 MILLILITER) ASCENDING AORTIC PSEUDOANEURYSM AT MGH (BOSTON), AN IMPEDE-FX-12 PLUG MIGRATED. THE CASE INVOLVED DR. (B)(6) (VS, PRIMARY), DR. (B)(6) (CVS), DR. (B)(6) (IC), AND TRAINEES. AFTER FEMORAL ACCESS AND MULTIPLE ARCH AORTOGRAMS, A 45-MINUTE C-ARM MALFUNCTION DELAYED PROGRESS. THE SAC WAS EVENTUALLY ACCESSED USING A VERT AND VANSCHIE 3 CATHETER, FOLLOWED BY A 7F TOURGUIDE AND 5F X 110CM COOK FLEXOR SHEATH. DR. (B)(6) ADVANCED A 7FX90CM TOURGUIDE STEERABLE TIP GUIDE CATHETER (OVERALL LENGTH WAS 105 CENTIMETERS), BUT WAS UNABLE TO GET INTO SAC AND SETTLED FOR HAVING THE TIP POSITIONED 2 TO 3 CENTIMETERS AWAY (WHICH REDUCED THE AMOUNT OF BACKUP SUPPORT PROVIDED TO THE PLUG DELIVERY CATHETER/SHEATH). TWO IMPEDE-FX-12 PLUGS WERE DEPLOYED SUCCESSFULLY, BUT THE THIRD MIGRATED INTO THE AORTA. THE SHEATH WITH TWO UNDEPLOYED PLUGS WAS REMOVED. IMAGING COULD NOT LOCATE THE MIGRATED PLUG, BUT IT WAS CONFIRMED THAT IT WAS NOT LOCATED IN THE HEAD, NECK, ARMS OR TORSO, AND THAT ALL RADIAL AND PEDAL PULSES WERE PALPABLE. A NON-SMM PLUG WAS PLACED AT THE SAC ENTRY AND A CT SCAN LATER SHOWED THE MIGRATED PLUG L

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23313428 ↗
• MalfunctionJun 23, 2025Malposition of Device; Migration; Malposition of Device; Migration

  ON (B)(6) 2025, DURING TREATMENT OF AN ENDOLEAK AT THE IPSILATERAL FEMORAL ARTERY, AN IMP-FX-12 PLUG MIGRATED AND WAS NOT DELIVERED AT THE TARGET SITE. THE PATIENT HAD AN INTERPOSITION GRAFT (BETWEEN CORONARY ARTERIES AND BRACHIO-CEPHALIC) WITH AN ENDOLEAK AT THE DISTAL SUTURE LINE WITH AN INCREASING ANEURYSM. THE CT WAS REVIEWED PRIOR TO THE PROCEDURE AND IT APPEARED LARGER THAN WHAT WAS OBSERVED DURING THE CASE. THE ENDOLEAK WAS ACCESSED FROM THE GROIN USING A SHORT 7F SHEATH AND 7F LAUNCHER GUIDING CATHETER. SOME DIFFICULTY ACCESSING THE LESION WAS REPORTED AND ANOTHER CURVED TIP 7F LAUNCHER WAS USED. THE ENDOLEAK WAS IDENTIFIED AS SMALL AND THE PHYSICIAN DECIDED TO IMPLANT 1 IMP-FX-12. UPON FEEDING THE IMP-FX-12 THROUGH THE GUIDING CATHETER, THE GUIDING TIP JUMPED OUT OF THE ENDOLEAK WITH THE PLUG INSIDE THE CATHETER AND WAS MOVED BACK INTO THE ENDOLEAK AND PROCEEDED WITH PUSHING THE PLUG. AT THE CURVED TIP OF THE CATHETER, THE IMP-FX-12 PLUG JUMPED OUT OF THE CATHETER, KICKING IT PROBABLY OUT OF THE ENDOLEAK AGAIN. THE PLUG DISAPPEARED. ACCESS WAS RE-ATTEMPTED WITH A STRAIGHT 7F LAUNCHER OVER A 0.038 CATHETER BUT THE ENDOLEAK SEEMED TO HAVE SHRUNK EVEN MORE IN SIZE AND ANOTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22311324 ↗
• MalfunctionJun 19, 2025Migration; Migration

  ON (B)(6) 2025 AT (B)(6) MEDICAL CENTER IN (B)(6) USA, DURING TREATMENT OF A TEVAR AND SMA STENT/EMBOLIZATION AN IMP-FX-12 PLUG MIGRATED AND WAS NOT DELIVERED AT THE TARGET SITE. THE IMP-FX-12 PLUG WAS PLANNED FOR EMBOLIZATION OF THE SMA DISSECTION AFTER A SELF-EXPANDING STENT WAS DEPLOYED IN THE SMA TRUE LUMEN. DURING DEPLOYMENT OF THE IMP-FX-12 PLUG, THE PLUG TRAVELED INTO THE INFRARENAL AORTA. IT IS UNKNOWN IF THE 5F SHEATH USED TO DELIVER WAS IN THE RIGHT LOCATION. DR. (B)(6) DECIDED TO LEAVE THE PLUG IN THE INFRARENAL AORTA AND CONTINUE WITH THE PROCEDURE AS A 2ND IMP-FX-12 PLUG WAS DEPLOYED AND IMPLANTED AT THE TARGET LOCATION - THE SMA DISSECTION. THE PHYSICIAN THEN STOPPED THE PROCEDURE AFTER THE FLUOROSCOPY STOPPED WORKING. ON (B)(6) 2025, IT WAS INITIALLY REPORTED BY THE SHAPE MEMORY MEDICAL (SMM) EMPLOYEE FAMILIAR WITH THE CASE THAT THE 1ST IMP-FX-12 PLUG TRAVELED INTO THE INFRARENAL AORTA. ON (B)(6) 2025, FROM A FOLLOW-UP EMAIL REGARDING THE CASE, IT WAS REPORTED BY ANOTHER SMM EMPLOYEE FAMILIAR WITH THE CASE THAT THE 1ST IMP-FX-12 TRAVELED TO THE FALSE LUMEN OF THE AORTA AND THE PHYSICIAN DID NOT FIND IT A CONCERN TO LEAVE THE IMP-FX-12 PLUG IN THIS LOCATION; THE IMP-F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294159 ↗
• InjuryJun 3, 2025Migration; Migration

  THIS PATIENT HAS UNDERGONE MULTIPLE PROCEDURES RELATED TO THE IMP-FX-12, AS DESCRIBED BELOW: (B)(6) 2024: (B)(4) IMP-FX-12 DEVICES IMPLANTED TO TREAT AN ENDOLEAK AROUND AN ENDOGRAFT THAT WAS PREVIOUSLY IMPLANTED (B)(6) 2024: RETREATMENT OF ENDOLEAK. DURING RETREATMENT, THE PHYSICIAN NOTICED IMP-FX-12 PLUGS MIGRATED TO THE RENAL BRANCH AND INTERNAL ILIAC. INTERNAL ILIAC PLUG WAS JAILED WITH A STENT, RESTORING FLOW. FLOW WAS AVAILABLE TO THE KIDNEY VIA OTHER BRANCHES, SO RENAL WAS NOT TREATED. THE SUBJECT OF THIS COMPLAINT/REPORT IS AS FOLLOWS: ON (B)(6) 2025, THE TREATING PHYSICIAN (B)(6) NOTIFIED SHAPE MEMORY MEDICAL THAT, DURING FOLLOW-UP WITH THIS PATIENT, THE PATIENT WAS SYMPTOMATIC WITH CLAUDICATION. UPON FURTHER EXAMINATION, (B)(6) FOUND THAT IMP-FX-12 PLUGS HAD MIGRATED TO THE LEFT PROFUNDA ARTERY AND TO BILATERAL POPLITEAL ARTERIES. THEY PHYSICIAN INDICATED THAT THE OCCLUSION OF THE POPLITEAL IS THE CAUSE OF CLAUDICATION. (B)(6) ATTEMPTED TO TREAT THE PATIENT ENDOVASCULARLY WITHOUT SUCCESS. HE PLANS TO PERFORM A BYPASS SURGERY TO THE PATIENT'S LOWER RIGHT LEG. THE EXACT QUANTITY OF PLUGS IN EACH ARTERY IS YET TO BE CONFIRMED. TO SHAPE MEMORY MEDICAL'S KNOWLEDGE, THE BYPASS P

  Patient problems: Foreign Body Embolism; Limb Pain

  MAUDE report 22133151 ↗
• MalfunctionMay 29, 2025Malposition of Device; Malposition of Device

  NOTE: THIS IS A FOLLOW UP REPORT TO THE INITIAL REPORT FILED UNDER THE SAME NUMBER ON 05/14/2025. NO PRIOR INFORMATION IS REPEATED WITHIN THIS REPORT. NO ADDITIONAL INFORMATION FROM THE SMM PERSONNEL PRESENT DURING THE CASE AND FROM THE SMM PERSONNEL AWARE OF BUT NOT PRESENT DURING THE CASE WAS PROVIDED TO THE COMPLAINT INVESTIGATOR. BASED ON THE INFORMATION RECEIVED, THE ROOT CAUSE OF DELIVERING THE PLUGS OUTSIDE OF THE ANEURSYM MAY HAVE BEEN DUE TO THE PROCEDURE/USER TECHNIQUE WHERE IT WAS REPORTED THAT THE DELIVERY CATHETER PENETRATED THE ANEURYSM WALL. DEPLOYMENT AND/OR MIGRATION TO AN UNINTENDED LOCATION IS AN ANTICIPATED RISK THAT IS CAPTURED IN THE IMPEDE-FX RISK MANAGEMENT DOCUMENTATION (UFMEA1002 REV E). THE RISK CAN BE CRITICAL, DEPENDING ON THE ANATOMICAL LOCATION OF THE MIGRATION AND/OR UNINTENDED PLACEMENT. IN THIS CASE, THE PLUGS WERE DEPLOYED OUTSIDE OF THE ANEURYSM AND NO PATIENT HARM WAS REPORTED. NO FURTHER REINTERVENTIONS WERE MADE.

  Patient problems: Aneurysm expansion

  MAUDE report 22108098 ↗
• MalfunctionApr 3, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025 AT (B)(6) CENTER, DR. (B)(6), WAS TREATING A TYPE 1 ENDOLEAK ON A 72 HOUR PREVIOUSLY IMPLANTED, PHYSICIAN MODIFIED (LASER FENESTRATIONS) MDT ENDURANT AND SUCCESSFULLY RESCUED AN IMPEDE FX-12 WITH AN ENSNARE. DR. (B)(6) WAS USING A 6FR TOURGUIDE STEERABLE SHEATH TORQUED 180° WITH A 6FR MDT LAUNCHER JR4.0 GUIDING CATHETER TO DELIVER PLUGS INTO A POSTERIOR PORTION OF THE AORTA THAT HAD ANEURYSMAL DEGENERATION AND LACKED GRAFT TO VESSEL APPOSITION, DUE PARTLY TO ENFOLDING OF THE ENDOGRAFT. TWO PLUGS WERE SUCCESSFULLY DEPLOYED AND THE 3RD PLUG BEGAN KICKING THE GUIDECATH BACK AS HE PUSHED WITH A 260CM BENTSEN WIRE. THE PLUG EXITED THE CATHETER AT THE VERY PROXIMAL EDGE OF THE STENT GRAFT THEN FOLLOWED THE CATHETER OUT OF THE POSTERIOR OUTPOUCHING AND INTO THE AORTA FIXATING INTO THE SUPRARENAL STENT OF THE GRAFT WHEN DR. (B)(6) RETRACTED THE CATH TO REPOSITION. USING THE ENSNARE HE DISLODGED THE PLUG FROM THE SUPRARENAL STENT WHILE ATTEMPTING TO SNARE AND IT TRAVELED DOWN THE AORTA AND SETTLED AT THE SG'S BIFURCATION JUST ABOVE THE CONTRALATERAL LIMB. DR. (B)(6) WAS ABLE TO SNARE AND COMPLETELY RECOVER THE PLUG FROM THE PATIENT. THE LOT NUMBER OF THE PLUG IS UNKNOWN. DR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767351 ↗
• MalfunctionMar 19, 2025Migration; Migration

  WHILE TREATING A PATIENT DURING A CARTO CASE, AN IMP-FX-12 PLUG (LOT #FR24072501U) WAS LODGED IN A SUB-SEGMENTAL BRANCH OF THE LEFT LUNG (LINGULAR BRANCH). DR. (B)(6), MD AT (B)(6) PERFORMED A TIPS PROCEDURE. ACCESS WAS VIA THE LEFT INTERNAL JUGULAR AND THE FEMORAL SINCE THE RIGHT INTERNAL JUGULAR WAS OCCLUDED. ACCESS WAS ALSO DIFFICULT DUE TO A DEFIBRILLATOR IN PLACE. THE SHUNT WAS CREATED WITH A GORE VIATORR TIPS GRAFT WHERE THERE IS A PORTION WITH OPEN STENT STRUTS AND MOST OF ITS LENGTH IS PTFE COVERED. THE GOAL OF THE CARTO WAS TO EMBOLIZE A LARGE VERICELE TO PREVENT ITS RUPTURE. AMPLATZER PLUGS WERE TO BE USED TO ACT AS A BACKSTOP IN A LARGE SECTION OF THE VESSEL (MEASURING ABOUT 18 MM IN DIAMETER). IN TOTAL 2 IMP-10 (LOT #F23090701E) AND 15 IMP-FX-12 (10 LOT #FR24080601U AND 5 LOT #FR24072501U) WERE IMPLANTED. AFTER THE LAST FX PLUG WAS DELIVERED, THE IR RESIDENT AGGRESSIVELY FLUSHED THE SHEATH WHICH FORCED THE PLUG RETROGRADE INTO THE HEPATIC VEIN, THEN CELIAC, IVC, THROUGH THE RIGHT HEART AND INTO THE LUNG WHERE IT LODGED IN A SUB-SEGMENTAL BRANCH OF THE LEFT LUNG (LINGULAR BRANCH). DR. PROCELL DETERMINED THAT THE PLUG HAD LANDED VERY DISTAL AND THE INFARCT WAS SMALL AND W

  Patient problems: Foreign Body Embolism

  MAUDE report 21649206 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A PATIENT HAD SHAPE MEMORY MEDICAL INC.'S IMP-FX-12 DEVICES IMPLANTED TO EMBOLIZE A TYPE 2 ENDOLEAK POST ENDOVASCULAR REPAIR WITH AN ENDOGRAFT (NOT MANUFACTURED BY SMM). PERIGRAFT ACCESS ALONG THE RIGHT LIMB OF THE STENT GRAFT WAS USED TO OBTAIN ACCESS TO THE ENDOLEAK. THE DEVICES WERE ONLY PLACED IN THE MIDDLE-THIRD OF THE TARGET AREA AS NOT ALL PORTIONS OF THE ENDOLEAK WERE REACHABLE. DEPLOYMENT OF THE PLUGS WENT AS EXPECTED AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2024, THE PATIENT APPEARED TO HAVE AN INFECTION ON THE ANTERIOR ASPECT OF THE ANEURYSM SAC AND WAS TRANSFERRED TO BARNES-JEWISH HOSPITAL FOR FURTHER OBSERVATION. IT IS ASSUMED THAT THE INFECTION WORSENED AS THE PATIENT WAS THEN TRANSFERRED TO ANOTHER FACILITY AND UNDERWENT AN OPEN EXPLANT OF THE AORTIC STENT GRAFT AND SMM DEVICES. AFTER THE PATIENT UNDERWENT EXPLANTATION OF THE AORTIC STENT GRAFT AND IMP-FX-12 DEVICES SOMETIME BETWEEN (B)(6)2024 THROUGH (B)(6)2025, NO ADDITIONAL CLINICAL SEQUALAE WAS REPORTED. THE PATIENT WAS DISCHARGED AND IS IN STABLE CONDITION.

  Patient problems: Unspecified Infection

  MAUDE report 21164329 ↗
• DeathDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, DR. (B)(6) PERFORMED A STENT ON A HEPATIC ARTERY AND A SAC FILL OF A GASTRODUODENAL ARTERY (GDA) ANEURYSM WHERE 70 IMP-FX-12 PLUGS WERE PLACED USING A 7F MEDTRONIC LAUNCHER GUIDE CATHETER AND 180CM AMPLATZ S. S. GUIDEWIRE. THE PHYSICIAN ACCESSED THE HEPATIC ARTERY FIRST USING AN 8F X 90CM TERUMO DESTINATION SHEATH WHICH THE 7F MEDTRONIC LAUNCHER WAS DELIVERED INTO/THROUGH. THE PHYSICIAN ALSO USED 3 GORE VIABAHN VBX STENTS TO ELIMINATE PERFUSION OF THE GDA ANEURYSM. AT THE END OF THE PROCEDURE, EMBOLIZATION WAS COMPLETE, THERE WAS NO FLOW IN THE GDA ANEURYSM, AND NO PERFUSION OF THE SAC FROM THE HEPATIC ANEURYSM. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS IN STABLE CONDITION. THE PATIENT REMAINED IN THE HOSPITAL PER NORMAL PROCEDURE, BUT 3 DAYS LATER ON (B)(6) 2024 EXPERIENCED A RUPTURE OF THE ABDOMINAL ARTERY AND THE PATIENT EXPIRED. UNDER COMPUTED TOMOGRAPHY (CT) SCAN, THE PHYSICIAN COULD NOT IDENTIFY WHICH ARTERY WAS RUPTURED. IT WAS REPORTED THAT "DR. (B)(6) DOES NOT BELIEVE IT WAS THE GDA THAT RUPTURED, GIVEN THAT IT HAD BEEN EMBOLIZED AND EXCLUDED, I.E., NO LONGER PERFUSED AND PRESSURIZED BY THE HEPATIC ARTERY."

  Patient problems: Ruptured Aneurysm

  MAUDE report 20838956 ↗
• MalfunctionNov 27, 2024Malposition of Device; Malposition of Device

  PATIENT WAS TREATED FOR TYPE II ENDOLEAK ON 09/23/2024 USING 70 IMPEDE-FX DEVICES (IMP-FX-12) AFTER BEING DIAGNOSED WITH TYPE II ENDOLEAK AND EXPANDING AORTA. THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED INCIDENTS. DURING THE 30 DAY FOLLOW UP SCAN ON 10/24/2024, IT WAS NOTICED THAT SOME OF THE DEVICES APPEAR TO BE LOCATED IN OR ON THE AORTIC WALL AND BETWEEN THE THROMBUS AND THE AORTIC WALL. THE PATIENT STATUS WAS STABLE AND NO SERIOUS ADVERSE EVENT WAS REPORTED. NO FURTHER RE-INTERVENTION WAS PERFORMED. THE PHYSICIAN SCHEDULED THE PATIENT FOR FOLLOW UP APPOINTMENTS TO CONTINUE TO MONITOR. LOT NUMBERS OF IMP-FX-12 DEVICE USED: LOT#FR24041101U, QTY: 44, EXP DATE: 2027-08-06, MANUFACTURING DATE: 05/06/2024; LOT#FR24062810U QTY: 10, EXP DATE: 2027-10-15, MANUFACTURING DATE: 07/15/2024; LOT#FR24040501U QTY: 11, EXP DATE: 2027-07-23 MANUFACTURING DATE: 04/23/2024; LOT#FR24062501U QTY: 5, EXP DATE: 2027-09-28 MANUFACTURING DATE: 06/28/2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799097 ↗
• MalfunctionNov 27, 2024Migration; Migration

  ON (B)(6) 2024, DR (B)(6) AT (B)(6) PERFORMED AN EMBOLIZATION OF AN OVARIAN VEIN WHERE 6 OF 7 IMP-FX-12 PLUGS WERE DELIVERED AT THE TARGET SITE USING A 6F CORDIS CATHETER. 1 IMP-FX-12 PLUG HAD MIGRATED AND LANDED IN A SUB-SEGMENTAL PULMONARY ARTERY THAT WAS PERFUSING A SMALL PART OF THE LUNG. DR (B)(6) OPTED NOT TO ATTEMPT TO RETRIEVE THE MIGRATED PLUG AS THERE WAS NO PATIENT SEQUELAE. THE PROCEDURE WAS COMPLETED AND PATIENT IS IN STABLE CONDITION. NO ADVERSE EVENT HAS BEEN REPORTED THUS FAR.

  Patient problems: Pulmonary Embolism

  MAUDE report 20791081 ↗
• MalfunctionNov 26, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024 AT (B)(6) HOSPITAL, A PATIENT WAS UNDERGOING A BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION (BRTO) PROCEDURE AND AN IMP-FX-12 DEVICE WAS PLACED IN THE HEPATIC VEIN BY AN INTERNAL JUGULAR VEIN APPROACH. THE VASCULAR DIAMETER WAS FROM 7 MM TO 11 MM AND THE EMBOLIZATION AT THE 7MM POINT WAS EXPECTED AND PLACED WITHOUT PROBLEMS. ON (B)(6) 2024, THE PATIENT'S CONDITION WAS CHECKED WITH A COMPUTED TOMOGRAPHY (CT) SCAN WHICH SHOWED THAT THE PLACED IMP-FX-12 DEVICE DID NOT EXPAND TO 12 MM AND DID NOT FIT THE VESSEL. THERE WAS SPACE BETWEEN THE VESSEL AND THE IMP-FX-12 DEVICE. NO MIGRATIONS AND HEALTH DAMAGE TO THE PATIENT WERE REPORTED ON (B)(6) 2024. ANOTHER FOLLOW-UP WITH THE PATIENT WAS CONDUCTED ON (B)(6) 2024 AND IT WAS FOUND THAT THE TARGET AREA HAD NOT FULLY EMBOLIZED. THE PATIENT WAS DISCHARGED WITH NO HEALTH DAMAGE AND IN STABLE CONDITION. THE SURGEON WILL CONTINUE TO OBSERVE THE PATIENT FOR APPROXIMATELY 2 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 20780545 ↗
• MalfunctionNov 21, 2024Malposition of Device; Migration; Malposition of Device; Migration

  ON (B)(6) 2024, DR (B)(6) AT (B)(6) PERFORMED AN EMBOLIZATION OF AN ABERRANT SUBCLAVIAN ARTERY WHERE AN IMP-10 WAS PLACED IN THE VESSEL AND AN FX-12 WAS ADDED BEHIND THE IMP-10, WHICH WERE BOTH PLACED USING A 6 FR. FLEXOR SHEATH. UPON OBTAINING AN ANGIOGRAM, IT WAS DISCOVERED THAT THE FX-12 HAD MIGRATED PAST THE IMP-10, AND WAS NOW SITTING IN THE RIGHT DISTAL SUBCLAVIAN ARTERY. AN EN SNARE WAS ADVANCED, AND THE PLUG WAS CAPTURED. WHILE RETRACTING THE PLUG BACK, IT WAS RELEASED AT THE SAME LEVEL AS THE ANCHOR COIL OF THE IMP-10. HE DECIDED TO LEAVE IT THERE, THEN PROCEEDED WITH THE PROCEDURE. AS PART OF TREATING THE ABERRANT SUBCLAVIAN ARTERY, TWO (2) TERUMO RELAY THORACIC GRAFTS WERE PLACED ACROSS THE OSTIUM OF THE ABERRANT SUBCLAVIA AND A RIGHT CAROTID TO RIGHT SUBCLAVIAN BYPASS WAS PERFORMED. WHILE INTERROGATING THE RESULTS OF THE PROCEDURE, THE FX-12 WAS NOTICED TO HAVE MIGRATED AGAIN TO THE RIGHT AXILLARY AREA. THE MIGRATED PLUG WAS SNARED AND REMOVED FROM THE PATIENT VIA THE EXPOSED CAROTID SUBCLAVIAN BYPASS. IT IS POSSIBLE THAT THE ENTIRE POLYMER PORTION OF THE PLUG WAS NOT FULLY REMOVED. THE PATIENT IS STABLE AND HAD GOOD PERFUSION TO THE HAND, AS MEASURED BY PULSE-OXIMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20752516 ↗
• MalfunctionOct 1, 2024Malposition of Device; Malposition of Device

  THIS WAS A FOLLOW UP CASE/RE-TREATMENT, PERFORMED ON (B)(6) 2024, TO TREAT A CHRONIC ENDOLEAK. THE ORIGINAL CASE TOOK PLACE ON (B)(6) 2024. DURING THE ORIGINAL CASE, 30 IMP-FX-12 PLUGS WERE USED TO TREAT THE ENDOLEAK. DURING FOLLOW UP/RE-TREATMENT ON (B)(6) 2024, IT WAS DISCOVERED THAT TWO IMP-FX-12 PLUGS FROM THE ORIGINAL CASE HAD MIGRATED FROM THE AORTA TO THE INTERNAL ILIAC AND RENAL ARTERIES. FLOW WAS RESTORED TO THE INTERNAL ILIAC WITH A STENT. FLOW WAS AVAILABLE TO THE KIDNEY VIA SIDE BRANCHES, SO NO ADDITIONAL MEASURES WERE TAKEN REGARDING THE IMPLANT IN THE RENAL ARTERY.

  Patient problems: Foreign Body Embolism

  MAUDE report 20346964 ↗
• MalfunctionAug 15, 2024Malposition of Device; Malposition of Device

  A PATIENT WITH AN ANEURYSM FILLED WITH FENESTRATED EVAR WAS BEING TREATED WITH SMM PLUGS AFTER PLACING THE EVAR GRAFT. WHILE DEPLOYING THE IMP-FX-12 DEVICES, IT WAS NOTICED THAT SOME PLUGS HAD GONE INTO THE COMMON ILIAC ARTERIES. IT WAS CONFIRMED VIA INTRAVASCULAR ULTRASOUND (IVUS) THAT THE PLUGS WERE WITHIN THE LUMEN OF THE ENDOGRAFT. THE ENDOGRAFT WAS RELINED WITH ILIAC EXTENSIONS UP TO THE RENAL ARTERIES WHICH JAILED THE PLUGS IN THE LUMEN. TWO IMP-FX-12 DEVICES WERE NOTED IN EACH INTERNAL ILIAC ARTERY FOR A TOTAL OF FOUR IMPLANTS. INSERTION OF AN ENDOGRAFT EXTENSION WITHIN THE ORIGINAL GRAFT EFFECTIVELY 'JAILED' THE PLUGS BETWEEN THE ORIGINAL GRAFT AND ENDOGRAFT EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997253 ↗
• MalfunctionJun 5, 2024Malposition of Device; Malposition of Device

  A PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM WAS PREVIOUSLY TREATED WITH AN ENDOVASCULAR GRAFT (NOT MANUFACTURED BY SMM). LATER THE PATIENT PRESENTED WITH A TYPE 2 ENDOLEAK WHERE THE ANEURYSM HAD ALSO GROWN 1 CM AND AS A RESULT REQUIRED REINTERVENTION WHERE THE IMPEDE-FX (SMM) DEVICE WAS USED. THE PHYSICIAN GAINED ACCESS TO THE ANEURYSM/ENDOLEAK CAVERN VIA PERIGRAFT THROUGH THE RIGHT LIMB AND SHOT CONTRAST INTO THE SAC CONFIRMING APPROPRIATE SHEATH PLACEMENT. THE PHYSICIAN THEN ADVANCED THE SHEATH HIGHER INTO THE SAC. MID-PROCEDURE, FLUOROSCOPIC IMAGING WAS PERFORMED, AND IT WAS FOUND THAT CONTRAST, AS WELL 6 IMPEDE-FX DEVICES AND EXTRAVASATION WAS OBSERVED UNINTENTIONALLY OUTSIDE THE ANEURYSM. THE PHYSICIAN PROCEEDED WITH THE PROCEDURE AND DELIVERED ADDITIONAL IMPEDE-FX DEVICES AS PLANNED PRE-PROCEDURALLY. A THROMBIN SLURRY (NOT MANUFACTURED BY SMM) WAS ALSO INJECTED INTO THE TARGET SITE TO COMPLETE THE PROCEDURE. THE FINAL IMAGING CONFIRMED THAT NO NEW CONTRAST WAS LEAKING OUTSIDE OF THE AORTA. IT IS POSSIBLE THAT THE SHEATH ADVANCEMENT HIGHER INTO THE SAC PUSHED THE GUIDEWIRE THROUGH THE ANEURYSM WALL WHICH LED TO THE DEVICES BEING UNINTENTIONALLY DEPLOYED OUTSIDE OF THE TARGET S

  Patient problems: Extravasation

  MAUDE report 19470445 ↗
• MalfunctionMay 7, 2024Malposition of Device; Malposition of Device

  THE DEVICES WERE BEING USED TO TREAT AN ENDOLEAK. AFTER INITIAL ACCESS, IT WAS OBSERVED VIA ANGIOGRAPHY THAT THERE WAS A PERFORATION IN THE AORTIC WALL CAUSED BY THE BENTSON WIRE BEING USED. 70 IMP-FX-12 PLUGS WERE THEN DELIVERED, AND IT WAS NOTED THE PERFORATION APPEARED TO HAVE RESOLVED WITH THE DELIVERY OF THE IMPEDE-FX DEVICES. THE REMAINDER OF THE CASE WAS UNEVENTFUL, AND NO ABNORMALITIES WERE NOTICED DURING IMAGING. THE PATIENT REPORTED HAVING LOWER LEFT QUADRANT PAIN AND MALAISE POST-OPERATION. A FOLLOW UP CT WAS CONDUCTED IN RESPONSE TO THE LLQ PAIN, WHICH HAD IMPROVED BUT HAD NOT ENTIRELY RESOLVED SINCE THE PROCEDURE. DURING THE CT, IT WAS OBSERVED THAT SEVERAL IMP-FX-12 PLUGS (APPROXIMATELY 5-10) HAD MIGRATED OUTSIDE OF THE AORTIC WALL. THERE WAS NO INTERVENTION TO ADDRESS THE MIGRATED PLUGS AND THE LATEST UPDATE IS THAT THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Abdominal Pain; Malaise

  MAUDE report 19262166 ↗
• DeathApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING TREATED FOR TYPE II ENDOLEAK USING IMPEDE-FX EMBOLIZATION PLUG (IMP-FX-12) DEVICE. TRANSCAVAL ACCESS WAS GAINED AND 70 PLUGS WERE DELIVERED TO THE TARGET SITE WITHOUT ANY INCIDENT USING A 6FR JR4 (CORDIS) SHEATH. AFTER COMPLETION OF THE DEPLOYMENT WHILE WITHDRAWING THE DELIVERY SHEATH FROM THE AORTIC ACCESS, THE PATIENTS BLOOD PRESSURE IMMEDIATELY DROPPED. RESUSCITATION WAS STARTED HOWEVER THE PATIENT DID NOT RECOVER AND EXPIRED. NOTE: THIS REPORT IS A SUPPLEMENT TO MFR REPORT NUMBER# 3013353964-2024-00003 IDENTIFYING AN ADDITIONAL SUSPECT DEVICE IMP-FX-12, LOT#F23100701U.

  Patient problems: Extravasation; Low Blood Pressure/ Hypotension

  MAUDE report 19126894 ↗
• DeathApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING TREATED FOR TYPE II ENDOLEAK USING IMPEDE-FX EMBOLIZATION PLUG (IMP-FX-12) DEVICE. TRANSCAVAL ACCESS WAS GAINED AND 70 PLUGS WERE DELIVERED TO THE TARGET SITE WITHOUT ANY INCIDENT USING A 6FR JR4 (CORDIS) SHEATH. AFTER COMPLETION OF THE DEPLOYMENT WHILE WITHDRAWING THE DELIVERY SHEATH FROM THE AORTIC ACCESS, THE PATIENTS BLOOD PRESSURE IMMEDIATELY DROPPED. RESUSCITATION WAS STARTED HOWEVER THE PATIENT DID NOT RECOVER AND EXPIRED.

  Patient problems: Extravasation; Low Blood Pressure/ Hypotension

  MAUDE report 19122565 ↗