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

Model Number	9-ITV12F45/80
Medical Device Problem Codes	Biocompatibility (2886); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/20/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported on (b)(6) 2021, a 22mm amplatzer p.I.Muscular vsd occluder was implanted.During the procedure, the patient developed a pericardial effusion that was caused by the guides of the catheter when the operator tried to cross the second ventricular septal defect (vsd).Heart massages were performed and they tried to drain the effusion however, the patient died during procedure.Only one amplatzer p.I.Muscular vsd occluder was implanted.Operative notes were requested but are not available.
Additional Manufacturer Narrative
An event of pericardial effusion and patient death during procedure were 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.
Event or Problem Description
It was reported on (b)(6) 2021, a 22mm amplatzer p.I.Muscular ventricular septal defects (vsd) occluder was selected for implant, in a patient who had suffered a heart attack a few days prior to the procedure and had to be revived.It was noted that the patient had two vsds and closing the two vsds quickly was the only possibility to save the patient.During the procedure, the first vsd occluder was implanted.During the attempt to close the second vsd, the patient developed a pericardial effusion while the operator tried to cross the second vsd with a non-abbott (cook medical) stiff guidewire and a 9f amplatzer torqvue delivery system.Heart massages were performed and attempts were made to drain the effusion however, the patient died during procedure.It was reported that the cause of the pericardial effusion was the non-abbott (cook) stiff guidewire.Only one amplatzer p.I.Muscular vsd occluder was implanted.Operative notes were requested but are not available.No additional information was reported.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 12770516
• Report Number: 2135147-2021-00479
• Device Sequence Number: 4326590
• Product Code: DQY
• UDI-Device Identifier: 00811806010885
• UDI-Public: 00811806010885
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2021

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: 05/31/2023
• Device Model Number: 9-ITV12F45/80
• Device Catalogue Number: 9-ITV12F45/80
• Device Lot Number: 7553330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 80 KG