MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT; VALVE REPAIR

Catalog Number CDS0502

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

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/15/2020

Event Type  Death  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Patient id: (b)(6).It was reported that on 12/06/2018, the patient presented with functional mitral regurgitation (mr) grade 4+, with pure annular dilation, mitral leaflet calcification, and mitral leaflet flail.Two mitraclips were implanted without a device issue, reducing the mr to grade 2+.On (b)(6) 2020, the patient expired.This information was obtained from a family call to the account.No other specifics were known.Per physician, the death is unknown if related to the device.There was no device malfunction noted.No additional information was provided regarding this issue.

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 the reported event.In this case, there was no reported device malfunction associated with clip delivery system.The reported patient effect of death, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the available information, a cause for the reported death could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11267393
• MDR Text Key: 229901212
• Report Number: 2024168-2021-00795
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• 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: 02/11/2021

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: 08/10/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80810U112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MITRACLIP; MITRACLIP
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Weight: 55