MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Catalog Number 9-ACP2-010-025

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Pericardial Effusion (3271)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on 28 november 2023, a 25mm amplatzer amulet occluder was successfully implanted in a patient.It was noted 23 hours post-implant, that there was a puncture of the circumflex artery.The decision was made to perform a pericardiocentesis and rush to patient to surgery.A small pin sized hole in the circumflex artery that was noted and was squirting blood out.The hole was repaired and a small patch was also placed on the circumflex artery to help prevent reoccurrence.It was noted that the patient's heart was very dynamic and hyperactive.The patient was doing well and discharged at the time of report.

Event Description

It was reported that on (b)(6) 2023, a 25mm amplatzer amulet occluder was successfully implanted in a patient.It was noted 23 hours post-implant, that there was a puncture of the circumflex artery.The decision was made to perform a pericardiocentesis and rush to patient to surgery.A small pin sized hole in the circumflex artery that was noted and was squirting blood out.The hole was repaired and a small patch was also placed on the circumflex artery to help prevent reoccurrence.It was noted that the patient's heart was very dynamic and hyperactive.The patient was doing well and discharged at the time of report.Subsequent to the previously filed report, additional information was received that the 25mm amplatzer amulet occluder had been implanting using a 12f amplatzer torqvue 45x45 delivery sheath.It was noted that the patient had been administered heparin for procedure and had an activated clotting time of 324 seconds.It was noted that the occluder had been placed with 2/3 of the lobe distal to the circumflex artery during implant.There were no difficulties implanting the 25mm amplatzer amulet occluder and it was implanted in one deployment with zero manipulations.The occluder had been sized using echocardiogram measurements.It physically visualized during surgery, that the stabilizing wire of the 25mm amplatzer amulet occluder had punctured the circumflex artery.It was also noted that the patient did develop a pericardial effusion, but it was drained prior to onset of cardiac tamponade.The patient was doing well and discharged at the time of report.

Manufacturer Narrative

An event of perforation, hemorrhage/blood loss/bleeding, and pericardial effusion were reported.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 for the reported incidents appeared to be related to procedural conditions.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER AMULET
• 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: 18377463
• MDR Text Key: 331178704
• Report Number: 2135147-2023-05673
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: 00811806013497
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 8853373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male