MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number 9-PDA-003

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hemorrhage/Bleeding (1888); Foreign Body Embolism (4439)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

Situation: an infant with congenital heart and lung disease was sent to the catheterization laboratory for hemodynamic assessment and possible intervention.There were complications during the case requiring surgical intervention and extracorporeal membrane oxygenation (ecmo).Background: patient is an infant with a genetic lung mutation (filamin a), pulmonary hypertension, congenital heart disease (vsd, asd, pda (patent ductus arteriosus (pda) - heart defect)), and biventricular dysfunction, who was intubated since birth, and had a prior ecmo course at the referring facility.He was transferred for high-risk lung or heart-lung transplantation evaluation, possible tracheostomy, and possible surgical or transcatheter intervention on his heart defects.As a part of this transplant evaluation he was sent to the catheter lab for hemodynamic assessment, vasoreactivity testing, and possible pda closure.Following diagnostic testing in the catheter lab, there was a multidisciplinary discussion with the pulmonary hypertension, icu, surgery, and catheter lab teams.There was agreement that primary surgical closure of the defects had intolerable risk, and plan was to proceed with transcatheter pda closure followed by more aggressive medical ph (pulmonary hypertension) therapy.Assessment: after the pda device was placed, the device embolized to the aorta.During attempted transcatheter device retrieval, there was injury to the right iliac vein.Surgical intervention was required to control bleeding and to retrieve the embolized device.The patient was brought back to the icu on ecmo support.This device was disposed.Case reviewed - no deviations from generally accepted practice standards identified.Thoughtful consideration of risks before and during procedure, appropriate response to procedural complication with thoughtful interdisciplinary discussion and decision making.Device migration is a known complication and is discussed during pre-procedural consult with family.

• Brand Name: AMPLATZER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 26531 ynez road; temecula CA 92591
• MDR Report Key: 13677682
• MDR Text Key: 286650132
• Report Number: 13677682
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9-PDA-003
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 7538185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Date Report to Manufacturer: 03/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Sex: Male