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 Hemorrhage/Bleeding (1888)

Event Date 11/24/2020

Event Type  Injury  

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.Based on available information, a cause for the reported hemorrhage could not be determined.The reported patient effect of hemorrhage is listed in the mitraclip system instructions for use, and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment was a result of case-specific circumstances, as the right groin was treated to stop the bleeding.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report the bleeding requiring intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.During insertion of the steerable guide catheter (sgc), arterial bleeding occurred therefore the sgc was removed.The access site was switched to the left groin and the procedure continued with a new sgc.Two clips were implanted, reducing mr to 2.After the procedure, the right groin was treated to stop the bleeding.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• 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: 10937712
• MDR Text Key: 219316236
• Report Number: 2024168-2020-10124
• 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: Physician
• Type of Report: Initial
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00830U106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention