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

Catalog Number CDS0602-NTR

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

Patient Problems Thrombosis (2100); Transient Ischemic Attack (2109)

Event Date 01/13/2021

Event Type  Injury  

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

This is filed to report thrombosis and transient ischemic attack.It was reported that on (b)(6) 2021, a mitraclip procedure was performed to treat mitral regurgitation (mr) with a grade of 3.One clip was successfully implanted, reducing mr to a grade of <1.The following day, the patient suffered a transient ischemic attack (tia) potentially due to thrombogenic event.The physician also stated that the patient suffered potentially small embolic lesions.No additional treatment was performed, and the patient is noted to be in stable condition.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 to the reported lot which would have contributed to the reported issues.Based on this information, a cause for the reported thrombosis could not be determined.The reported transient ischemic attack was a cascading effect of the reported thrombosis.Thrombosis and transient ischemic attack are listed in the mitraclip system instructions for use and 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 NTR CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11293398
• MDR Text Key: 230716271
• Report Number: 2024168-2021-00936
• 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: 03/04/2021

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: 05/21/2021
• Device Catalogue Number: CDS0602-NTR
• Device Lot Number: 00520U141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other