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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, a 25mm amplatzer patent foramen ovale (pfo) occluder was chosen for a pfo closure procedure, along with a 9f amplatzer torqvue delivery system.The device was sized and successfully implanted using micro-transesophageal echocardiography (tee).There were no complications noted during the implant procedure.During the night after the implantation, the patient woke up and had blood on the femoral compression at the access site of the delivery system from the procedure.The patient became bradycardic, and the physician suspected that the patient became bradycardic from the sight of the blood.The cause of the femoral bleeding was unknown, and it is unknown how much femoral bleeding was present.Femoral compression was performed to treat the bleeding.The physician gave the patient a sternal punch to treat the bradycardia, and the patient recovered.The next day, a transthoracic echocardiogram (tte) and a transesophageal echocardiography (tee) were performed.The left disc of the device was well apposed in the left atrium, but the right disc was partially in the right atrium and partially in the pfo.The patient was discharged from the hospital as the device was stable.The patient will be scheduled in (b)(6) 2022 to correct the issue of the right atrial disc.The physician believes that the cause of migration was the sternal punch and the short length of the patient's pfo.The patient status was reported as stable.No additional information was provided.Related manufacturer report number: 2135147-2022-00059.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Subsequent to the initially filed information, the following information was received reported that the patient did not require a blood transfusion.On (b)(6) 2022, the patient had a successful implantation of a 30mm amplatzer pfo occluder to complete the pfo closure and stabilize the first device.No additional information was reported.
Additional Manufacturer Narrative
An event of bleeding at the access site 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
• 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: 13452552
• Report Number: 2135147-2022-00060
• Device Sequence Number: 20306527
• Product Code: DQY
• UDI-Device Identifier: 00811806010861
• UDI-Public: 00811806010861
• 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): 03/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 9-ITV09F45/80
• Device Catalogue Number: 9-ITV09F45/80
• Device Lot Number: 7938058
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 02/27/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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
• Patient Sex: Female