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

Catalog Number CDS0702-XTW

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

Patient Problems Cardiac Enzyme Elevation (1838); Thrombosis/Thrombus (4440)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

The device is not returning.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 conservatively report thrombus.It was reported this was a mitraclip procedure to treat grade 4 functional mitral regurgitation (mr).When attempting the transseptal puncture, prior to inserting the steerable guide catheter (sgc), thrombus was observed on the transseptal needle.The transseptal puncture was successful, the sgc was inserted and thrombus was aspirated over the sgc.Thereafter, the sgc was removed and flushed with saline and the sgc and mitraclip delivery system were inserted, and st-elevation was observed.Heparin was given and the st-elevation disappeared.The mitraclip procedure was continued, one clip was implanted, reducing mr to <1.It is unknown if the mitraclip devices caused or contributed to the thrombus and st elevation.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.The reported patient effects of cardiac enzyme elevation and thrombosis as listed in the mitraclip g4 system instructions for use (ifu), are known possible complications associated with mitraclip procedures.Based on this information, a cause for the reported thrombus could not be determined.The reported cardiac enzyme elevation was a result of the reported thrombus.The reported unexpected medical intervention and medication required were a result of case specific circumstances as the thrombus had to be aspirated and heparin was administered.There is no indication of a product 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 VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11510246
• MDR Text Key: 240597017
• Report Number: 2024168-2021-02137
• 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: 05/21/2021

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: 09/04/2021
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 00902U448
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention