MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

Catalog Number SGC0302

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

Patient Problem Thrombosis (2100)

Event Date 06/17/2020

Event Type  Injury  

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. Based on the information reviewed, a conclusive cause for the thrombosis could not be determined. The reported patient effect of thrombosis is listed in the mitraclip system instructions for use (ifu), as a known possible complication associated with mitraclip procedures. There is no indication of a product issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report the thrombosis. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 3. The steerable guide catheter (sgc) was inserted into the patient when thrombosis was visible at the puncture site in the left atrium (la). The procedure was continued with one clip implanted, reducing mr to 1+. The thrombosis was no longer visible at the end of the procedure. There was no clinically significant delay in the procedure and no adverse patient sequela.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10253295
• MDR Text Key: 198191842
• Report Number: 2024168-2020-05604
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/30/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00131U204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/09/2020 Patient Sequence Number: 1