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

Model Number	9-TV2-07F120
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an amplatzer valvular plug iii 12mm x 5m was implanted on (b)(6) 2022., post procedure, but prior to discharge from hospital, acute right limb ischemia with right common femoral occlusion due to right femoral artery dissection with thrombus formation was observed and was treated with right iliofemoral endarterectomy with bovine patch with improvement of symptoms.The patient was reported to be in stable condition.
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 acute right limb ischemia with right common femoral occlusion due to right femoral artery dissection with thrombus formation 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information : (b)(6) - paradigm, patient site id: (b)(6).It was reported that a 7f amplatzer torqvue 2 delivery system was used to implant a 12mm x5mm amplatzer valvular plug iii on (b)(6) 2022.Post procedure, but prior to discharge from hospital, acute right limb ischemia with right common femoral occlusion due to right femoral artery dissection with thrombus formation was observed and was treated with right iliofemoral endarterectomy with bovine patch with improvement of symptoms.On (b)(6) 2022, patient had right lower extremities pain and swelling; the patient was prescribed doxycycline for presumed cellulitis.On (b)(6) 2022, the patient presented to the emergency department (ed) with no relief of symptoms and additional fever and chills.The patient was admitted and diagnosed with cellulitis of leg.Iv antibiotics were started and the patient was later transitioned to oral antibiotics prior to discharge.The patient was reported to be in stable condition.

• 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: 14892286
• Report Number: 2135147-2022-00461
• Device Sequence Number: 17690318
• Product Code: DQY
• UDI-Device Identifier: 00811806012551
• UDI-Public: 00811806012551
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2026
• Device Model Number: 9-TV2-07F120
• Device Catalogue Number: 9-TV2-07F120
• Device Lot Number: 8046425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2021
• 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: Unknown
• Patient Race: White