AMPLATZER™ 9-AVP2-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00811806010410), received between Jul 9, 2018 and Feb 6, 2026 — classified as 15 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A 16MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT USING AN NON-ABBOTT DELIVERY SYSTEM. FOLLOWING DEPLOYMENT AND RELEASE OF THE DEVICE, THE PHYSICIAN OBSERVED THAT RESIDUAL BLOOD FLOW CONTINUED TO PASS THROUGH THE TREATED VESSEL. THE LEAK WAS OBSERVED AS A PARAVALVULAR LEAK AND MEASURED 1.2MM. THE LEAK WAS OBSERVED THROUGH X-RAY AND CARDIAC ULTRASOUND. THE PROCEDURE WAS STOPPED, AND THE DAMAGE WAS REPORTED. THE PHYSICIAN SUBSEQUENTLY REMOVED THE DEVICE USING THE DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED LATER THAT THE DEVICE WAS NOT RELEASED FROM THE DELIVERY SYSTEM. THE PHYSICIAN TRIED TO ROTATE THE GUIDE WIRE (DELIVERY CABLE) TO RELEASED THE DEVICE FROM THE DELIVERY SYSTEM, BUT HE SAW THE DEVICE ROTATED WITH THE GUIDE WIRE. SO, HE DECIDED TO CHANGE OTHER NEW ONE TO FINISH THE OPERATION. THE PROCEDURE WAS COMPLETED, AND THE PATIENT¿S FINAL OUTCOME WAS REPORTED AS SATISFACTORY WITH NO ADVERSE EFFECTS. IT WAS CONFIRMED THAT THE DEVICE WAS RELEASED FROM THE DELIVERY SYSTEM. THERE WERE NO CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283599 ↗
• InjuryDec 3, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A 16MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR IMPLANT USING AN UNKNOWN DELIVERY SYSTEM FOR THE PURPOSE OF EMBOLIZING THE HEPATIC VEIN, WHICH WAS MEASURED TO HAVE AN APPROXIMATE DIAMETER OF 10MM. THE PHYSICIAN HAD DETERMINED THE SIZING OF THE DEVICE BY CONSIDERING A 50% OVERSIZE, AS IT WAS A VEIN. ARTERIOGRAPHY HAD BEEN USED AS THE IMAGING MODALITY DURING THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN INFORMED RBG THAT THE IMPLANTED DEVICE HAD MIGRATED TO THE PATIENT¿S LUNG. THE MIGRATION HAD BEEN IDENTIFIED THROUGH A CT SCAN AND CT ANGIOGRAPHY. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE EMBOLIZATION WAS THAT THE FINAL POSITIONING OF THE PLUG MIGHT HAVE BEEN TOO DISTAL. A PROCEDURE FOR REMOVAL OF THE DEVICE WAS SCHEDULED FOR ON (B)(6) 2025. ON (B)(6) 2025, AN UPDATE WAS RECEIVED FROM THE DISTRIBUTOR REGARDING THE REMOVAL PROCEDURE. DURING THE ATTEMPT TO RETRIEVE THE MIGRATED PLUG FROM THE PATIENT¿S LUNG, THE DEVICE WAS GRASPED USING A SNARE AND SHEATH. WHILE EFFORTS WERE MADE TO RESHEATH THE DEVICE, THE PLUG SLIPPED OUT OF THE SNARE IN AN OPEN CONFIGURATION AND SUBSEQUENTLY MIGRATED TO THE ILIAC VEIN. NO LEAKAGE HAD BEEN DETECTED AROUND THE LOB

  Patient problems: Angina; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708840 ↗
• InjuryJul 17, 2025Separation Problem; Separation Problem

  N/A.

  Patient problems: Pain

  MAUDE report 22533041 ↗
• MalfunctionDec 10, 2024Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 16MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT IN THE INTERNAL ILIAC ARTERY (IIA) USING A 6F NON-ABBOTT DELIVERY SHEATH. DURING PROCEDURE, WHEN THE PLUG WAS INSERTED INTO THE NON-ABBOTT SHEATH AND DELIVERY WAS ATTEMPTED, BUT IT GOT STUCK INSIDE THE CATHETER. WHEN TRYING TO RETRIEVE THE PLUG, THE PLUG BODY DETACHED FROM THE WIRE, SO THE SYSTEM WAS REMOVED AND THE PLUG WAS RETRIEVED. THE SYSTEM WAS THEN SET UP AGAIN, AND A NEW 16MM AMPLATZER VASCULAR PLUG II WAS CHOSEN, PASSED THROUGH THE SAME DELIVERY SYSTEM WITHOUT ANY ISSUES AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897010 ↗
• InjuryFeb 8, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON 17 JAN. 2024, A 10MM AND 16MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT THE DIMENSION OF THE DEFECT MEASURED -8MM X 6MM AND WAS DONE BY ECHO, CT FUSION, AND FLUORO. DURING THE PROCEDURE, THE 10MM AMPLATZER VASCULAR PLUG II DEVICE BECAME DETACHED AFTER THE SHEATH WAS REMOVED AND EMBOLIZED IN THE LEFT VENTRICLE. THE PHYSICIAN TRIED TO IMPLANT A 16MM AMPLATZER VASCULAR PLUG II BUT ALSO EMBOLIZED IN THE LEFT VENTRICLE. THE DEVICES WERE BOTH SNARED NOTHING REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 16MM AMPLATZER VASCULAR PLUG II. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669121 ↗
• InjuryJan 17, 2024Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  CLINICAL INFORMATION: (B)(6) - PARADIGM. PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 9MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFUL IMPLANTED IN PATIENT. AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 8565272) WAS IMPLANTED FOR PERIVALVULAR BUT DID NOT COMPLETELY CLOSE PERIVALVULAR LEAKAGE (PVL). AN ADDITIONAL TWO AMPLATZER SEPTAL OCCLUDERS (LOT NUMBER: 8528784 AND 7712146) WERE IMPLANTED FOR CLOSURE OF PVL. TWO AMPLATZER VASCULAR PLUGS 2 (LOT NUMBER: 8813477) WERE RELEASED DURING PROCEDURE, BUT WERE PERCUTANEOUSLY REMOVED FOR UNKNOWN REASON. TWO AMPLATZER VALVULAR PLUGS 3 (9-APVL3IDE-105, SERIAL NUMBER: (B)(6)) AND (9-APVL3IDE-145, SERIAL NUMBER: (B)(6)) WERE ATTEMPTED FOR IMPLANT, BUT WERE PERCUTANEOUSLY REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. ONLY ONE NON-ABBOTT WAS USED THROUGHOUT THE WHOLE PROCEDURE. POST-IMPLANT IT WAS NOTED THAT THE PATIENT HAD A RESIDUAL SHUNT THAT RESULTED IN HEMOLYSIS AND HEMOGLOBINURIA. THE DECISION WAS MADE TO IMPLANT AN UNKNOWN SIZE AMPLATZER VASCULAR PLUG 2 USING A TRANS-SEPTAL APPROACH, AFTER A FAILED TRANS-APICAL APPROACH. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT DEVELOPED A LEFT HEMOTHORAX WITH AN APICAL LEFT VENTRICLE BLEE

  Patient problems: Insufficient Information

  MAUDE report 18527498 ↗
• InjuryJan 17, 2024Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  CLINICAL INFORMATION: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 9MM AMPLATZER SEPTAL OCCLUDER WAS SUCCESSFUL IMPLANTED IN PATIENT. AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 8565272) WAS IMPLANTED FOR PERIVALVULAR BUT DID NOT COMPLETELY CLOSE PERIVALVULAR LEAKAGE (PVL). AN ADDITIONAL TWO AMPLATZER SEPTAL OCCLUDERS (LOT NUMBER: 8528784 AND 7712146) WERE IMPLANTED FOR CLOSURE OF PVL. TWO AMPLATZER VASCULAR PLUGS 2 (LOT NUMBER: 8813477) AND (SERIAL NUMBER: UNKNOWN) WERE RELEASED DURING PROCEDURE, BUT WERE PERCUTANEOUSLY REMOVED FOR UNKNOWN REASON. TWO AMPLATZER VALVULAR PLUGS 3 (9-APVL3IDE-105, SERIAL NUMBER: (B)(6)) AND (9-APVL3IDE-145, SERIAL NUMBER: (B)(6)) WERE ATTEMPTED FOR IMPLANT, BUT WERE PERCUTANEOUSLY REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. ONLY ONE NON-ABBOTT WAS USED THROUGHOUT THE WHOLE PROCEDURE. POST-IMPLANT IT WAS NOTED THAT THE PATIENT HAD A RESIDUAL SHUNT THAT RESULTED IN HEMOLYSIS AND HEMOGLOBINURIA. THE DECISION WAS MADE TO IMPLANT AN UNKNOWN SIZE AMPLATZER VASCULAR PLUG 2 USING A TRANS-SEPTAL APPROACH, AFTER A FAILED TRANS-APICAL APPROACH. ON (B)(6) 2023, IT WAS NOTED THAT THE PATIENT DEVELOPED A LEFT HEMOTHORAX WITH AN APICAL LEFT VENTRICLE BLEED FROM

  Patient problems: Insufficient Information

  MAUDE report 18527232 ↗
• InjuryNov 28, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER VASCULAR PLUG 2 WAS IMPLANTED IN A LEFT ATRIAL APPENDAGE. AFTER THE PROCEDURE, THE PLUG GOT EMBOLIZED INTO LEFT ATRIUM AND HAD TO SNARED THAT OUT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGH OUT THE PROCEDURE. BUT THERE WAS A DELAY IN THE PROCEDURE WITH NO FURTHER ADVERSE PATIENT EFFECTS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220034 ↗
• MalfunctionSep 27, 2023Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826237 ↗
• MalfunctionJul 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR AN IMPLANT TO EMBOLIZED A PULMONARY ARTERY. THE PHYSICIAN POSITIONED THE DEVICE ACROSS THE PULMONARY ARTERY AND WAITED FOR 10 MINUTES THE EMBOLIZATION DIDN'T HAPPEN. THE PHYSICIAN REMOVED THE DEVICE AND LEFT PATIENT ON MEDICAL MANAGEMENT. THE PATIENT REMAIN HEMODYNAMICALLY STABLE, THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288465 ↗
• MalfunctionMay 22, 2023Fracture; Off-Label Use; Fracture; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT WITH AN UNKNOWN DELIVERY SYSTEM. DURING PROCEDURE, IT WAS NOTED VIA INTRAOPERATIVE ANGIOGRAPHY THERE WAS A HOLE IN THE DEVICE. A DECISION WAS MADE TO REMOVE THE DEVICE AND REPLACED WITH ANOTHER AMPLATZER VASCULAR PLUG II. THE FIRST DEVICE WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO FRACTURE/BREAKAGE OF THE NITINOL WIRES ON THE DEVICE AND THERE WAS NO NOTE OF PACKAGING DAMAGE PRIOR TO USE. IT WAS REPORTED THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THIS EVENT AND THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981355 ↗
• InjuryMar 1, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE "STRUCTURE CLUB JAPAN LIVE DEMONSTRATION 2022 (P.59)" WAS REVIEWED IT WAS REPORTED THAT ON MARCH OF AN UNKNOWN YEAR, A PATIENT HAD AN UNKNOWN MECHANICAL HEART VALVE IMPLANTED. IN NOVEMBER OF THE SAME YEAR, A PARAVALVULAR LEAK WAS FOUND, AND THE VALVE WAS REPLACED WITH ANOTHER UNKNOWN VALVE. IN MARCH OF A DIFFERENT UNKNOWN YEAR, THE PATIENTS CARDIAC INSUFFICIENCY EXACERBATED, AND THE PARAVALVULAR LEAK WAS OBSERVED AGAIN. IT WAS DEICED TO ATTEMPT PERCUTANEOUS PARAVALVULAR LEAK CLOSURE. THERE WERE 3 PARAVALVULAR LEAKS BETWEEN 6 O'CLOCK AND 9 O'CLOCK. IT WAS ALSO NOTED THAT THE ANNULUS WAS FLAILED PARTIALLY. A 4MM X 4MM AMPLATZER DUCT OCCLUDER II WAS IMPLANTED AT THE 9 O'CLOCK POSITION. THEN A 6MM X 4MM AMPLATZER DUCT OCCLUDER II WAS IMPLANTED IN THE 6 O'CLOCK, AND THE PARAVALVULAR LEAK WAS UNABLE TO BE CONTROLLED DUE TO THE FLAILED ANNULUS. THE 6MM X 4MM AMPLATZER DUCT OCCLUDER II THEN FELL OUT OF ITS ORIGINAL POSITION. A 16MM AMPLATZER VASCULAR PLUG II WAS THE IMPLANTED INTO THE 6 O'CLOCK POSITION. A 6MM X 4MM AMPLATZER DUCT OCCLUDER II WAS THEN IMPLANTED AT THE 8 O'CLOCK POSITION TO COMPLETE THE PROCEDURE. 7 DAYS POST OPERATIVELY THE 16MM AMPLATZER VASCULAR PLUG II EMBOL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464467 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ARTICLE FROM THE JAPANESE COLLEGE OF ANGIOLOGY REPORTED A CASE OF A 80 YEARS OLD FEMALE WHO HAD AORTIC DISSECTION WITH STANFORD B TYPE AND WAS BEING TREATED CONSERVATIVELY. AFTER 17 YEARS SINCE THE INITIAL OCCURRENCE, MARKED ENLARGEMENT OF FALSE LUMEN REVEALED VIA COMPUTERIZED TOMOGRAPHY (CT) SCAN. IT WAS DECIDED THAT THE PRIMARY ENTRY FOR 15MM WAS REQUIRED TO BE SEALED BY THORACIC ENDOVASCULAR ANEURYSM REPAIR (TEVAR) NAVION STENT GRAFT WAS IMPLANTED FROM ZONE 4 TO THE AREA OF SUB-DIAPHRAGMATIC. REGURGITATION FROM RE-ENTRY LOCATION TO FALSE LUMEN AT THE CENTRAL OF DESCENDING AORTA WAS DETECTED BY A POSTOPERATIVE ANGIOGRAPHY. CANDY-PLUG WAS CREATED AND INSERTED IN NOT DILATATED FALSE LUMEN AT THE LEVEL OF CELIAC ARTERY TO SUPERIOR MESENTERIC ARTERY. A-NON-ABBOTT PLUG WAS MADE AS FOLLOWING STEP. A CENTER OF A 36MM EXCLUDER AORTIC EXTENDER (MFR: GORE) WAS SEWED AND SHORTENED. A 16MM AMPLATZER VASCULAR PLUG II WAS INSERTED INTO THE NON-ABBOTT PLUG AND EMBOLIZATION COIL WAS DWELLED INTO THE VASCULAR PLUG AND IMPLANTED AROUND THE AVPII AS WELL. IT WAS CONFIRMED THAT FLOW INTO THE FALSE LUMEN DISAPPEARED POSTOPERATIVE CT. HOWEVER, DIAMETER OF ANEURYSM AT THE DISTAL OF DESCENDING AORTA

  Patient problems: Aneurysm

  MAUDE report 15849867 ↗
• MalfunctionSep 30, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON 28 JUNE 2022, A 16MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR PROCEDURE AFTER BEIG SIZED ACCORDING TO THE INSTRUCTION FOR USE. DURING PROCEDURE IT WAS DETERMINED THAT THE AMPLATZER VASCULAR PLUG 2 HAD BECOME STRETCHED AND DEFORMED WHILE ATTEMPTING TO IMPLANT IT. THE PROXIMAL SIDE OF THE PLUG WAS PROTRUDING INTO THE PATIENT'S LEFT EXTERNAL ILIAC ARTERY. THE DECISION WAS MADE TO REMOVE THE 16MM AMPLATZER VASCULAR PLUG 2 AND REPLACE IT WITH A 12MM AMPLATZER VASCULAR PLUG 2. IT WAS NOTED THAT THE 16MM AMPLATZER VASCULAR PLUG 2 WAS REMOVED PRIOR TO BEING RELEASED FROM THE DELIVERY CABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATION. THE PATIENT REMAIN HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15510432 ↗
• MalfunctionAug 31, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 16MM AMPLATZER VASCULAR PLUG 2 (AVP2) WAS SELECTED FOR AN EMBOLIZATION OF THE PATIENT'S LEFT INTERNAL ILIAC ARTERY. A 6F NON-ABBOTT GUIDING SHEATH HAD BEEN INSERTED THROUGH THE PATIENT'S RIGHT FEMORAL ARTERY. EMBOLIZATION OF THE PATIENT'S BIFURCATION OF THE INFERIOR GLUTEAL ARTERY AND THE SUPERIOR GLUTEAL ARTERY WAS PERFORMED USING A NON-ABBOTT DEVICE. THE 16MM AVP2 WAS THEN PLACED MEDIAL TO THE ENTRANCE OF THE LEFT INTERNAL ILIAC ARTERY, BUT THE PROXIMAL LOBE OF THE AVP2 WAS SLIGHTLY DEPLOYED INTO THE EXTERNAL ILIAC ARTERY. THE DECISION WAS MADE TO ATTEMPT THE RECAPTURE OF THE AVP2, BUT THE DISTAL LOBE WAS DEFORMED. IT WAS NOTED THAT RESISTANCE OF THE DISTAL LOBE WAS WAS FELT WHEN TRYING TO RECAPTURE THE AVP2. THE DECISION WAS MADE REMOVE THE 6F NON-ABBOTT GUIDING SHEATH AND THE 16MM AVP2. THE 6F NON-ABBOTT GUIDE SHEATH WAS REINSERTED AND A REPLACEMENT 16MM AMPLATZER VASCULAR PLUG WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATIONS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15325668 ↗
• InjuryJul 18, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 16MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR AN IMPLANT ON (B)(6) 2022. AFTER DE-ATTACHMENT OF THE 1 MM AMPLATZER VASCULAR PLUG II, THE PLUG GOT LOOSE AND MIGRATED TO THE LUNGS. AN ATTEMPT TO REMOVE THE DEVICE IN AN ENDOVASCULAR FASHION OCCURRED BUT THE PLUG GOT STUCK IN THE RIGHT ATRIUM. THE PATIENT WAS CONVERTED TO CARDIAC SURGERY TO EXPLANT THE PLUG. THE PATIENT NEEDED RE-OPERATION DUE TO A BLEEDING, BUT RECOVERED WITHOUT COMPLICATIONS. IT WAS NOTED THAT THE PATIENT WAS IN STABLE CONDITION AND HAD BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 15048156 ↗
• InjuryApr 18, 2021Off-Label Use; Migration; Off-Label Use; Migration

  ON (B)(6) 2021, A 16MM AMPLATZER VASCULAR PLUG II WAS IMPLANTED. ON (B)(6) 2021, MIGRATION OF THE PLUG WAS OBSERVED AND INCREASED REGURGITATION OF THE TRICUSPID VALVE WAS OBSERVED. PERCUTANEOUS RETRIEVAL OF THE PLUG WAS ATTEMPTED, HOWEVER UNSUCCESSFUL. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO PUT THE PLUG BACK IN PLACE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. CLINICAL STUDY PATIENT ID: (B)(6).

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 11683380 ↗
• InjuryMar 19, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2021 A 16MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR A AORTIC PARAVALVULAR ANEURYSM PROCEDURE. DURING PLACEMENT THE PHYSICIAN VERIFIED THE DEVICE PLACEMENT AND THE DEVICE WAS RELEASED. UPON RELEASE, THE DEVICE EMBOLIZED INTO THE RIGHT ATRIUM AND BECAME TRAPPED IN THE LIGAMENTS OF THE TRICUSPID VALVE. ATTEMPTS WERE MADE TO RETRIEVE THE DEVICE AND THE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT WAS TAKEN TO OR FOR SURGICAL REMOVAL. THE SURGERY WAS CONFIRMED A SUCCESS. NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529546 ↗
• MalfunctionDec 29, 2019Misassembly by Users; Misassembly by Users

  ON (B)(6) 2019, A 16MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN DISCOVERED THE DEVICE WAS DAMAGED WHILE INSERTING IN THE LOADING SYSTEM. THE DEVICE AND THE DELIVERY SYSTEM WERE RETRIEVED AND THE CASE GOT CANCELED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9528808 ↗
• InjuryNov 30, 2018Mechanical Problem; Mechanical Problem

  ON (B)(6) 2018, A 16MM AMPLATZER VASCULAR PLUG II (AVPII) WAS SELECTED FOR IMPLANT. AFTER BEING DEPLOYED THE DEVICE WAS UNABLE TO BE RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS EXCHANGED FOR AN 18MM AVPII (LOT NUMBER: 6268259) BUT THE SAME ISSUE OCCURRED WHICH EXTENDED THE PROCEDURE BY MORE THAN THIRTY MINUTES. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8121698 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018, A 16MM AMPLATZER VASCULAR PLUG II (AVP2) WAS SELECTED FOR IMPLANT IN KRICHENKO TYPE C PATENT DUCTUS ARTERIOSUS (PDA). DURING THE PROCEDURE, THE 16MM AVP2 WAS DELIVERED THROUGH AN 8F GUIDING CATHETER (MACH1/BOSTON SCIENTIFIC, TYPE UNKNOWN) BY A FEMORAL VEIN PUNCTURE AND WAS SUCCESSFULLY DEPLOYED IN THE PATIENT'S DUCTUS. AFTER DEPLOYMENT OF THE AVP2, THERE WAS NO DEFORMATION OF AVP2 AND THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. POSTOPERATIVELY, THE PATIENT REMAINED FULLY CONSCIOUS STATE AND IN A STABLE CONDITION AND WAS TRANSFERRED TO A GENERAL WARD. ON (B)(6) 2018, THE PATIENT SUDDENLY HAD BACK PAIN AFTER A MEAL. THE CONTRAST ENHANCED CT WAS PERFORMED AND IT REVEALED THAT STANFORD TYPE A AORTIC DISSECTION WAS OBSERVED PERIPHERALLY AROUND THE DEPLOYED AVP2. SURGERY WAS IMMEDIATELY PERFORMED FOR ASCENDING AORTIC REPLACEMENT, AORTIC ARCH REPLACEMENT, AND DEPLOYMENT OF A STENT GRAFT. THE PDA WAS SURGICALLY CLOSED. THE PATIENT IS BEING CONTROLLED UNDER VENTILATOR AND HIS HEMODYNAMIC HAS BEEN STABLE AFTER RE-OPERATIVE SURGERY. THE CAUSE OF THE DISSECTION IS UNKNOWN; HOWEVER, PER REPORT THE USER CONSIDERED THAT THE AVP2 MAY HAVE BEEN TOO LARGE FOR THE DEFECT OR THE DE

  Patient problems: Cardiac Perforation

  MAUDE report 7774627 ↗
• InjuryJul 9, 2018Missing Information; Missing Information

  ON AN UNKNOWN DATE, A 16 MM AMPLATZER VASCULAR PLUG II (AVPII) WAS IMPLANTED. ON AN UNKNOWN DATE, THE AVPII WAS EXPLANTED DUE TO UNKNOWN REASONS. ADDITIONAL INFORMATION IS REQUESTED.

  Patient problems: No Information

  MAUDE report 7670861 ↗