MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

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

Patient Problems Mitral Valve Stenosis (1965); Pleural Effusion (2010)

Event Date 10/22/2021

Event Type  Death  

Event Description

This report is being filed due to mitral stenosis and is conservatively filed as a death, unknown if device related.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with mixed mitral regurgitation (mr), with pure annular dilatation, bileaflet prolapse, mitral annular calcification.Two mitraclips were implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2021, the discharge echocardiogram showed a mean mitral valve gradient of 9mmhg and mitral stenosis was diagnosed.There was no treatment reported.On (b)(6) 2021, another follow-up echocardiogram was performed.The mean mitral valve gradient had decreased to 6mmhg.Reportedly there was no mitral stenosis.On (b)(6) 2022, the patient had passed away.Reportedly, the site was made aware of the death from the patients wife, and additional details are not available.No additional information was provided regarding this issue.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported mitral stenosis and death could not be determined.The reported patient effects of mitral stenosis and death as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the final report, the additional information was received: on (b)(6) 2022, the patient was admitted to the hospital.A pacemaker was placed, and thoracentesis performed.The patient was subsequently discharged to rehab and a skilled nursing facility.

Manufacturer Narrative

A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on available information, the cause of the reported pleural effusion could not be determined.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There remains no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16248877
• MDR Text Key: 308197221
• Report Number: 2135147-2023-00300
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 10811R136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 02/14/2023; 03/28/2023
• Supplement Dates FDA Received: 03/08/2023; 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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
• Treatment: 1 IMPLANTED MITRACLIP.
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 79 KG