MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER POST-INFARCT VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-VSDMUSCPI-022

Device Problem Difficult to Fold, Unfold or Collapse (1254)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

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 (b)(6) 2024, a 22mm amplatzer post-infarct muscular vsd occluder was chosen for implant using an 12f amplatzer trevisio intravascular delivery system.During the release of the device, it had a cobra deformation.The deformed device was never released from the delivery cable while inside the patient.The device was recaptured after some attempts.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 24mm amplatzer post-infarct muscular vsd occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.

Manufacturer Narrative

An event of device deformity could not be confirmed.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.Information from the field indicated that there was no anatomical interference, or any angulation or kink in the delivery system upon deployment.A returned device assessment could not be performed as the device 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.

Event Description

It was reported that on (b)(6) 2024, a 22mm amplatzer post-infarct muscular vsd occluder was chosen for implant using an 12f amplatzer trevisio intravascular delivery system.During the release of the device, it had a cobra deformation.The deformed device was never released from the delivery cable while inside the patient.The device was recaptured after some attempts.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 24mm amplatzer post-infarct muscular vsd occluder was chosen and completed the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.

• Brand Name: AMPLATZER POST-INFARCT VSD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18894451
• MDR Text Key: 337550647
• Report Number: 2135147-2024-01103
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040040
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-VSDMUSCPI-022
• Device Lot Number: 8512244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 63 KG