MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER CARDIAC PLUG

Catalog Number 9-ACP-007-020

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Pericardial Effusion (3271)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 20mm amplatzer cardiac plug was implanted successfully utilizing a 12f amplatzer torqvue delivery system.Landing zone was 12mm x 18mm.The device was implanted with the right disc sitting on the left upper pulmonary (lupv) ridge.On 24 january 2024, the patient returned with pericardial effusion and dyspnea.The device was observed to have slid down the (lupv) ridge due to tension over time and was sitting on the transverse sinus.The effusion was drained via pericardiocentesis.The patient was reported to be stable.No further intervention was performed to treat the migration.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of pericardial effusion and migration was reported.A medical review of imaging received from the field was conducted and revealed that a "trace" quantity of pericardial fluid is observed posteriorly in sequences 3-5.No leaks are observed, and close criteria were met.The 40-degree view shows no change in the "trace" effusion noted at the initiation of the implant.The provided angiographic implant images show a chicken wing laa subsequently closed with a pseudo-sandwich implant.Offset and disc/lobe separation are noted consistent with the close criteria met in the tee images.Information from the field indicated that a pericardial effusion was detected after a follow up echocardiogram showed the amulet disc impinging upon the ts.However, those images are not available for review and no clinically significant pericardial effusion can be identified.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER CARDIAC PLUG
• Type of Device: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18712054
• MDR Text Key: 335476590
• Report Number: 2135147-2024-00684
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP-007-020
• Device Lot Number: 8800385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 66 YR
• Patient Sex: Male