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

Catalog Number 9-VSDMUSCPI-020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 02/20/2024

Event Type  Death  

Event Description

It was reported that on (b)(6) 2024, a 20mm amplatzer muscular ventricular septal defect (vsd) occluder was chosen for implant, using 10f amplatzer torqvue delivery system.The patient presented for an urgent post-infarct ventricular septal defect (pi-vsd) procedure.The patient had requested a do not resuscitate (dnr) with no surgical bailout option.The patient was believed to have a 10-day old rupture of the ventricular septum following a myocardial infarction (mi), measuring around 10mm on ct imaging.The tissue was soft so a 20mm pi-vsd device was chosen.Patient had a balloon pump in the aorta prior to the procedure.A transjugular approach was used.The procedure appeared to be going well and the device was sitting nicely in place.Pericardial effusion was observed on echocardiogram at this point.The device was released and looked good on imaging.The patient quickly deteriorated after this and subsequently expired.It is not clear what caused this to happen.

Manufacturer Narrative

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

Manufacturer Narrative

An event of death and pericardial effusion were reported.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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Furthermore, this complaint was reviewed by medical affairs.The reviewer stated that, "a patient with a post-infarct vsd underwent vsd closure via a right jugular venous approach 7 days after the acute mi.The patient developed a pericardial effusion intra-operatively requiring pericardiocentesis and ultimately died.The cause of death is most likely patient related due to the acute mi and procedure related.".

• 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: 18915142
• MDR Text Key: 337796285
• Report Number: 2135147-2024-01142
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-VSDMUSCPI-020
• Device Lot Number: 8647201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2022
• 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
• Treatment: AMPLATZER TORQVUE DELIVERY SYSTEM.
• Patient Outcome(s): Required Intervention; Other; Death
• Patient Age: 84 YR
• Patient Sex: Female