MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET DELIVERY SHEATH (12 FR AND 14 FR 80 CM DEVICES)

Model Number DS-TV45X45-14F-080

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2021, a 25mm amplatzer amulet was selected for implant using a 14f amplatzer amulet delivery sheath via the right femoral vein.The amulet was successfully implanted.Post-procedure, right femoral access ooze was observed and femostop and steri strips were applied.Of note, post-septal puncture, procedural transoesophageal echocardiogram (toe) showed a small residual left-right atrial shunt, however no treatment was required.On (b)(6) 2021, the patient was discharged home in stable condition.Clinical study (b)(6).

Manufacturer Narrative

An event of small left-right residual shunt was reported.A more comprehensive assessment could not be performed as the device remains implanted 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 AMULET DELIVERY SHEATH (12 FR AND 14 FR 80 CM DEVICES)
• Type of Device: AMPLATZER AMULET DELIVERY SHEATH
• 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: 12813812
• MDR Text Key: 282930127
• Report Number: 2135147-2021-00482
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: DS-TV45X45-14F-080
• Device Lot Number: 7186858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 108 KG