AMPLATZER™ 9-PLUG-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00811806011493), received between Sep 25, 2018 and Feb 6, 2024 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2024Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT A 14MM AMPLATZER VASCULAR PLUG WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE IT WAS ACKNOWLEDGED THAT USE OF A VASCULAR PLUG FOR A PATENT DUCTUS ARTERIOSUS DEFECT WAS CONSIDERED OFF-LABEL USE. THE PATIENT WAS NOTED TO HAVE AN UNUSUAL PDA SHAPE DEFECT. THERE WERE NO DIFFICULTIES NOTED WITH IMPLANTING THE DEVICE. THE PHYSICIAN APPLIED SLIGHT TENSION TO THE PUSHER WIRE PRIOR TO DEVICE DETACHMENT FROM THE DELIVERY SYSTEM. THE DEVICE WAS IMPLANTED SUCCESSFULLY. ON (B)(6) 2024, THE DEVICE WAS DETECTED TO HAVE MIGRATED. THE DEVICE WAS RECAPTURED VIA TRANSCATHETER SNARE AND REMOVED FROM THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW ATRIAL SEPTAL DEFECT (ASD) DEVICE. THE PHYSICIAN STATED THAT THE MIGRATION WAS NOT DUE TO THE DEVICE BUT THE PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18652786 ↗
• MalfunctionOct 10, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿INTERMEDIATE AND LONG-TERM FOLLOW-UP OF TRANSCATHETER CLOSURE OF CONGENITAL CORONARY CAMERAL FISTULAS IN INFANTS AND CHILDREN: EXPERIENCE FROM A SINGLE CENTER¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 2.25-YEAR-OLD, 10KG PATIENT WITH A CORONARY CAMERAL FISTULA AND CORONARY ARTERY ANEURYSM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 14MM AMPLATZER VASCULAR PLUG WAS CHOSEN FOR IMPLANT TO OCCLUDE A CORONARY CAMERAL FISTULA. IT WAS REPORTED 3 MONTHS POST-PROCEDURE, A LARGE RESIDUAL SHUNT WAS NOTED. THERE WAS NO TREATMENT REPORTED. THE ARTICLE CONCLUDED THAT TCC OF CCFS IN INFANTS AND CHILDREN APPEARS TO BE EFFECTIVE AND IS ASSOCIATED WITH A RELATIVELY LOW COMPLICATION RATE. LARGE CCFS AND GIANT CORONARY ARTERY ANEURYSMS (CAAS) REPRESENT A HIGHER RISK OF BOTH ACUTE AND INTERMEDIATE AND LONG-TERM ADVERSE EVENTS AFTER CLOSURE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ZHIWEI ZHANG, DEPARTMENT OF PEDIATRIC CARDIOLOGY, GUANGDONG CARDIOVASCULAR INSTITUTE, GUANGDONG PROVINCIAL PEOPLE¿S HOSPITAL (GUANGDONG ACADEMY OF MEDICAL SCIENCES), SOUTHERN MEDICAL UNIVERSITY, GUANGDONG PROVINCIAL KEY LABORATORY OF SOUTH CHINA STRUCTURAL HEART DISEASE, GUANGZHOU, 510100, CHINA,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908708 ↗
• InjuryAug 14, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2023-03527. THE ARTICLE, ¿A CHALLENGING INTERVENTIONAL PROCEDURE: TRANSCATHETER CLOSURE OF TUBULAR PATENT DUCTUS ARTERIOSUS IN PATIENTS WITH PULMONARY HYPERTENSION¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 1-YEAR-OLD, 6.6KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 7.9MM, AMPULLA DIAMETER = 7.8MM, DUCTAL LENGTH = 12.9MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 12MM AMPLATZER VASCULAR PLUG I WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER IMPLANT, IT WAS NOTED THE DEVICE HAD EMBOLIZED INTO THE PULMONARY ARTERY. A DECISION WAS MADE TO RETRIEVE AND EXPLANT THE EMBOLIZED DEVICE VIA TRANSCATHETER SNARE. A NEW 14MM AMPLATZER VASCULAR PLUG I WAS CHOSEN FOR IMPLANT. THE SECOND DEVICE ALSO EMBOLIZED INTO THE PULMONARY ARTERY AFTER RELEASE AND WAS ALSO EXPLANTED VIA TRANSCATHETER SNARE. A DECISION WAS MADE TO ADMIT THE PATIENT FOR SURGICAL LIGATION OF THE PDA. [THE PRIMARY AND CORRESPONDING AUTHOR IS ILKER KEMAL YUCEL, DEPARTMENT OF PEDIATRIC CARDIOLOGY, UNIVERSITY OF HEALTH SCIENCES DR. SIYAMI ERSEK THORACIC AND CARDIOVASCULAR SURGERY TRAINING AND RESEARCH HOSPITAL, ISTANBUL, TURKE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541279 ↗
• InjuryJun 28, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 14MM AMPLATZER VASCULAR PLUG WAS CHOSEN FOR IMPLANT WITH A 2.21MM INNER DIAMETER NON-ABBOTT DELIVERY SHEATH TO OCCLUDE A PUNCTURE OF THE SUBCLAVIAN ARTERY MEASURED 8-9MM DIAMETER FOLLOWING A THORACIC BYPASS GRAFT TO MODIFY BLOOD FLOW FOR A PLANNED 2 STAGE THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR). THE DEVICE WAS IMPLANTED AND COMPLETE OCCLUSION WAS CONFIRMED VIA ANGIOGRAPHY. THE FIRST STAGE OF TEVAR WAS PERFORMED AS SCHEDULED AND PROCEDURE WAS COMPLETED. IT WAS REPORTED THE FOLLOWING DAY, ON (B)(6) 2023, A CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THE VASCULAR PLUG HAD EMBOLIZED AND COMPLETELY DISLODGED FROM THE SUBCLAVIAN ARTERY ORIGIN TO NEAR THE ABDOMINAL ANEURYSM AT THE DISTAL RENAL ARTERY. IT WAS REPORTED THERE WAS NO PARTIAL OR COMPLETE OBSTRUCTION/BLOCKAGE OF BLOOD FLOW CAUSED BY THE EMBOLIZED DEVICE. THE SECOND STAGE OF THE TEVAR PROCEDURE WAS CONDUCTED IMMEDIATELY. PRIOR TO STENT GRAFT PLACEMENT, AN ATTEMPT TO RETRIEVE THE VASCULAR PLUG WAS MADE USING A SNARE DEVICE BUT WAS UNSUCCESSFUL. A DECISION WAS MADE TO COMPLETE THE TEVAR BY INSERTING THE STENT GRAFT PER NORMAL PROCEDURE TO POSITION THE VASCULAR PLUG BETWEEN TH

  Patient problems: Foreign Body In Patient

  MAUDE report 17219304 ↗
• DeathSep 25, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018, A 14MM AMPLATZER VASCULAR PLUG (AVP) WAS SELECTED TO CLOSE THE CAROTID ARTERY DURING A TAVR PROCEDURE. AFTER THE PLUG WAS RELEASED, THE DEVICE MOVED TO THE AORTA. A 14MM AMPLATZER VASCULAR PLUG 2 (LOT NUMBER: 4645198) WAS THEN PLACED AND SUCCESSFULLY EMBOLIZED THE TARGET VESSEL AND THE TAVR PROCEDURE CONTINUED. FOLLOWING THE TAVR PROCEDURE, THE PATIENT WAS TAKEN TO THE ICU FOR RECOVERY. LATER THAT NIGHT, THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM DUE TO A TAVR PROCEDURAL COMPLICATION AND DID NOT SURVIVE. THE USER DID NOT SUGGEST THE DEATH OR COMPLICATION WAS DUE TO EITHER VASCULAR PLUGS INVOLVED. THE USER'S ONLY CONCERN WAS THE MIGRATION OF THE 14MM AVP TO THE AORTA. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: Death

  MAUDE report 7908482 ↗