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

Catalog Number	9-TVLPC4F90/080
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of moderate tricuspid valve regurgitation 24 hours post procedure was reported.Since the device was not returned, abbott could not perform a device analysis to assess the stiffness of the delivery catheter used in this case.Based on the information received, the exact cause of the reported incident including the transient tricuspid valve regurgitation could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6)2023, a 5mm by 2mm amplatzer piccolo occluder was chosen for implant using a 4f amplatzer torqvue low profile catheter.The patent ductus arteriosus (pda) minimal diameter was measured to be 3.42mm.The pda diameter at the aortic ampulla was measured to be 3.50mm.The pda length was measured at 8.55mm.It was reported that the delivery catheter was too stiff and significantly manipulated the duct anatomy while attempting the place the device.A 4f non-abbott delivery sheath was used to access the pda via the right femoral vein approach.The inner diameter of the non-abbott delivery sheath were: 4 fr, 1.40 mm i.D.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.24 hours post procedure, it was observed that the patient experienced moderate tricuspid valve regurgitation via transesophageal echocardiogram (tee).On 7 march 2023, there was no noticeable tricuspid valve regurgitation seen on the tee.The patient was reported as stable and recovered.There was concern related to echo findings of tricuspid regurgitation that resolved "a couple weeks later" prior to discharge back to referring hospital nicu.The user believed that the delivery catheter placed back pressure on the tricuspid valve during delivery which caused the latent injury that was observed.The user also stated that the current delivery catheter significantly manipulates patient anatomy and causes concern for physicians.No additional information was provided.

• 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: 17376266
• Report Number: 2135147-2023-03139
• Device Sequence Number: 12358499
• Product Code: DQY
• UDI-Device Identifier: 00811806012926
• UDI-Public: 00811806012926
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 07/23/2023

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 Catalogue Number: 9-TVLPC4F90/080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/24/2023
• 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
• Patient Age: 30 WK
• Patient Sex: Female