MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE 2 DS; CATHETER, PERCUTANEOUS

Model Number	9-TV2-07F120
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	06/21/2022
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) 2022, an amplatzer valvular plug 3 and a 7f amplatzer torqvue 2 (tv2) delivery sheath were selected for procedure to close a septal paravalvular leak (pvl) in a previously implanted non-abbott mechanical mitral valve.An antegrade approach was used via transseptal puncture.Reportedly, the 7f tv2 delivery sheath was unable to be advanced successfully, and the leak was difficult to reach using a non-abbott introducer and non-abbott guidewire.The decision was made to replace the 7f tv2 delivery sheath with another 6f amplatzer torqvue 2 (tv2) delivery sheath over the wire.The 6f tv2 delivery sheath was also difficult to advance.The patient's blood pressure and oxygen dropped.Pericardial effusion occurred, and the patient flatlined.Reanimation was attempted, but ultimately the patient passed away.There was no kink or angulation noted in either the 7f tv2 or the 6f tv2, and patient was not reported to have tortuous anatomy.The hemostasis valve was used for both the 7f tv2 and the 6f tv2.The cause of the pericardial effusion was unknown, there was difficulty with advancing all mentioned devices through the patient's anatomy.Therefore this event is being conservatively reported for death as the cause is unknown.
Additional Manufacturer Narrative
An event of unable to advance the delivery system to the implant site, pericardial effusion, and patient death was reported.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.

• Brand Name: AMPLATZER TORQVUE 2 DS
• 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: 15063426
• Report Number: 2135147-2022-00547
• Device Sequence Number: 5711828
• Product Code: DQY
• UDI-Device Identifier: 00811806012551
• UDI-Public: 00811806012551
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162228
• 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): 10/05/2022

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: 07/31/2023
• Device Model Number: 9-TV2-07F120
• Device Catalogue Number: 9-TV2-07F120
• Device Lot Number: 7621203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE 2 DS, 9-TV2-06F-120 (7260209); AMPLATZER VALVULAR PLUG 3
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Female