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

Model Number	9-ITV09F45/80
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	06/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that a 14mm amplatzer muscular ventricular septal defect (vsd occluder was selected for implant using a 9f amplatzer torqvue delivery system for a high risk, post myocardial infraction (mi) vsd closure on (b)(6) 2021.The (b)(6) year old patient had a vsd that was measured via computerized tomography (ct), transesophageal echocardiogram (tee), and left ventricular (lv) angiography.The defect measurement was about 10-11mm.The delivery system was placed in the internal jugular (ij) access site.Prior to deployment, a small pericardial effusion and a drop in the patient's pressures were observed on echocardiogram (echo).The device was attempted to be placed, however was deemed too small.The patient developed tamponade and the occluder was re-sheathed and removed from the patient.Pericardiocentesis was performed.It was believed that the pericardial effusion occurred while gaining access and crossing the defect.The patient's rhythm changed and became unstable.It was noted that the patient was shocked several times.An 18mm amplatzer post-infarct muscular vsd occluder was then attempted to be implanted using the same delivery system and placed appropriately within the defect; confirmed by tee.The patient continued to code for one hour and was declared deceased.The 18mm device was never released from the cable and not implanted.It was noted that the physician did not believe death was related to the vsd devices, instead suspected tamponade was caused by cardiac perforation prior to device deployment.No additional information was provided.
Additional Manufacturer Narrative
An event of pericardial effusion, drop in "pressures", tamponade, arrhythmia, and patient death was reported.A more comprehensive 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.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12088476
• Report Number: 2135147-2021-00266
• Device Sequence Number: 19923227
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: 00811806010861
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 7655678
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 89 YR