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

Model Number 9-TV2-07F120

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hematoma (1884); Hemolytic Anemia (2279)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

(b)(6).On (b)(6) 2021 an amplatzer valvular plug iii was selected for implant in the patient with the following comorbidities: atrial fibrillation, gastrointestinal bleeding, hyperlipidemia, hypertension, duodenal angiodysplasia and previous mitral and aortic valve replacements(on-x valves).The patient's access site was through the femoral artery using a 7f amplatzer torqvue 2 delivery sheath.The plug was successfully implanted in the patient and remains implanted.On (b)(6) 2021, the patient experienced vascular access complications prior to discharge.A hematoma appeared on the patient's right thigh.A femoral artery fistula was observed some days after the procedure.The patient was treated with a compressive bandage and the event was resolved without sequelae on (b)(6) 2021.Additionally, the patients hemolytic anemia worsened and the patient was treated with transfusion of 2 concentrate.The patient is currently stable.

Manufacturer Narrative

An event of hematoma, femoral artery fistula, and hemolytic anemia was reported.A more comprehensive 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.

• Brand Name: AMPLATZER TORQVUE 2 DELIVERY SHEATH
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11903694
• MDR Text Key: 260485036
• Report Number: 2135147-2021-00210
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K093476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-TV2-07F120
• Device Catalogue Number: 9-TV2-07F120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 74