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

Catalog Number CDS0602-XTR

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

Patient Problems Dyspnea (1816); Mitral Regurgitation (1964); Tissue Damage (2104)

Event Date 12/03/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The clip remains implanted.Investigation has not yet been completed.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the initial mitraclip procedure was performed on (b)(6) 2019 to treat degenerative mitral regurgitation (mr) with a grade of 4.One clip (cds0602-xtr, 90725u184) was implanted successfully reducing mr to 1-2.On (b)(6) 2019, the patient was re-admitted with shortness of breath and mr grade of 4.Echocardiogram was performed and showed the clip well attached to both leaflets, but tissue damage was noted.On (b)(6) 2019, a second mitraclip procedure was performed to treat tissue damage and reduce mr.One clip (cds0601-xtr, 90828u148) implanted successfully, but mr was not reduced.Mr remained at 4 due to quality of the vessel tissue.The vessel tissue was fragile.No additional information was provided.

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.The investigation was unable to determine a conclusive cause for the tissue damage.The recurrent mitral regurgitation (mr) appears to be related to the tissue damage and the mr likely resulted in the dyspnea; therefore, attributed to procedural conditions.The reported patient effects of tissue damage, mr and dyspnea as listed in the instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9531909
• MDR Text Key: 176558186
• Report Number: 2024168-2019-15065
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

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: 07/25/2020
• Device Catalogue Number: CDS0602-XTR
• Device Lot Number: 90725U184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention