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

Catalog Number	9-TVLPC4F90/080
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event	12/28/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a 4f amplatzer torqvue lp delivery system was selected for a procedure on (b)(6) 2023 to treat a patent ductus arteriosus (pda).It was noted that there was difficulty cannulating the right ventricle, right atrium, and pda.Resistance was observed when first attempting to cross the duct with the catheter.The decision was made to withdraw the catheter to the pulmonary artery and advance the wire to ductus arteriosus.Resistance was observed during the second attempt to enter the duct.After repositioning the wire the patient presented with hypotension and bradycardia.It was noted that multiple wire exchanges were done.Echo imaging showed a pericardial effusion and pericardiocentesis was performed.The patient continued to become hemodynamically unstable and cpr was performed.Life-saving measures were performed.The patient expired.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of hypotension, bradycardia, pericardial effusion, cardiac tamponade and patient death was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that the resistance was observed when attempting to cross the duct with the catheter.It was also noted that multiple wire exchanges were made.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 respect to labeling design or manufacturing of the device.From medical review: the exact cause of death is unknown, but likely is due to difficulty crossing the ductus arteriosus with a presumed injury to the ductus arteriosus resulting in bleeding with a pericardial effusion.The cause of death is procedure related and possibly related to advancing the delivery catheter across a ductus arteriosus with vasospasm.

• Brand Name: AMPLATZER TORQVUE LP
• 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: 18527727
• Report Number: 2135147-2024-00274
• Device Sequence Number: 7597395
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: 00811806012926
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K131063
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

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 Catalogue Number: 9-TVLPC4F90/080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Age: 27 DA
• Patient Sex: Male