MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER P.I. MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-VSDMUSCPI-020

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tricuspid Valve Insufficiency/ Regurgitation (4453); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2021, an 18mm amplatzer p.I.Muscular vsd occluder was selected for implant, however was mis-sized as it was not stable on transesophageal echocardiogram (tee).A 20mm amplatzer p.I.Muscular vsd occluder was then selected, however, when deployed, the right disc showed a cobra deformation.After "several recaptures and redeployments,", the issue persisted.A new 20mm amplatzer p.I.Muscular vsd occluder was prepared to be exchanged.However, when removing the first 20mm device, one of the tricuspid chordae was damaged, resulting in significant tricuspid regurgitation.The patient was referred to surgery and was transferred to the operating room (or) in hemodynamically stable condition.However, the patient developed heart failure after emergency surgery after failed intervention and passed away.The user did not allege a malfunction with an abbott product and did not allege a relationship between the patient passing and an abbott product.

Manufacturer Narrative

The reported event of right disc showing cobra formation could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER P.I. MUSCULAR VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12751326
• MDR Text Key: 280116318
• Report Number: 2135147-2021-00460
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: SI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSDMUSCPI-020
• Device Lot Number: 8017074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2021
• 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; Death