MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	9-ITV08F180/80
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	05/03/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 16-14mm amplatzer duct occluder was chosen for procedure using a 7f amplatzer torqvue delivery system for a patient with a post-infarct ventricular septal defect (vsd).The patient had a myocardial infarction on (b)(6) 2023.The physician made the decision to chose an amplatzer duct occluder due to the vsd localization at the apex of the heart.Heparin was administered during procedure.The occluder was unable to be introduced inside the delivery system.The device was blocked at the entrance of the delivery system.After a few attempts, the decision was made to replace the delivery system with an 8f amplatzer torqvue delivery system.There were multiple manipulations to find the optimal position of the occluder.The occluder recaptured once before it was implanted.A pericardial effusion was noted at the apex of the heart.The activated clotting time (act) level was 360 seconds.A pericardiocentesis was performed with a reduction to the effusion.However, the pericardial effusion then developed into cardiac tamponade and was unable to be reversed.The patient died at the end of the procedure.The pericardial effusion was believed to be due to catheters and wire manipulations.The death was believed to be related to the procedure and the patient's comorbidities.
Additional Manufacturer Narrative
An event of difficulty positioning the device, pericardial effusion that led to cardiac tamponade and patient death at end of procedure was reported.The patient had history of myocardial infarction.Information from field indicated that there were multiple manipulations made to find optimal position and that the occluder was recaptured once before implantation.A pericardiocentesis was performed.The pericardial effusion was believed to be due to catheters and wire manipulations.The death was believed to be related to the procedure and the patient's comorbidities.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 16989583
• Report Number: 2135147-2023-02282
• Device Sequence Number: 7378589
• Product Code: DQY
• UDI-Device Identifier: 00811806010823
• UDI-Public: 00811806010823
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 9-ITV08F180/80
• Device Catalogue Number: 9-ITV08F180/80
• Device Lot Number: 7899430
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER DUCT OCCLUDER, 9-PDA-009, 7510272
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Male