IMPEDE-FX Embolization PlugRecalls & reported problems across all models

We found 3 models of IMPEDE-FX Embolization Plug by Shape Memory Medical Inc. in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Nov 9, 2021 and Mar 2, 2026 — classified as 5 deaths, 4 injuries, 26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported IMPEDE-FX Embolization Plug problems

IMPEDE-FX Embolization Plug models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• IMPEDE-FX Embolization Plug IMP-FX-12

  Device, Vascular, For Promoting Embolization
  5 deaths32 reports
• IMPEDE-FX Embolization Plug IMP-FX-06

  Device, Vascular, For Promoting Embolization
  2 reports
• IMPEDE-FX Embolization Plug IMP-FX-08

  Device, Vascular, For Promoting Embolization
  1 report

Recent IMPEDE-FX Embolization Plug adverse event reports

The 15 most recent reports across all models, 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 ↗