MAUDE Adverse Event Report: ABBOTT MEDICAL AMULET DELIVERY SHEATH 12F 80CM

Model Number DS-TV45X45-12F-080

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

Patient Problems Fistula (1862); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2021, a 22mm amplatzer amulet was implanted using a 12f amulet delivery sheath.On (b)(6) 2021, a small false bulge of the femoral artery up to 2cm in size was "half thrombosed" and an additional av fistula at the level of the femoral vessels was observed.Therefore, the patient underwent vascular revision.No patient consequences were reported.Clinical study patient id: (b)(6).

Event Description

On (b)(6) 2021, a 22mm amplatzer amulet was implanted using a 12f amulet delivery sheath.On 12 march 2021, a small false bulge of the femoral artery up to 2cm in size was "half thrombosed" and an additional av fistula at the level of the femoral vessels was observed.Therefore, the patient underwent vascular revision.No patient consequences were reported.Additional information received on 2 april 2021 reported that on (b)(6) 2021, a small hemodynamically insignificant circular pericardial effusion and pericardial fat were observed.Additional information received on 12 april 2021 reported that on (b)(6) 2021, a stationary 4mm pericardial effusion was observed at the right ventricle, however no treatment was required.Clinical study patient id: (b)(6).

Manufacturer Narrative

An event of a small false bulge of the femoral artery and an additional av fistula 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: AMULET DELIVERY SHEATH 12F 80CM
• Type of Device: AMULET DELIVERY SHEATH
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11589024
• MDR Text Key: 243335685
• Report Number: 2135147-2021-00117
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: DS-TV45X45-12F-080
• Device Lot Number: 7393469
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 104