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

Model Number SGC0301

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 01/31/2020

Event Type  Death  

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, the cause for the reported hemorrhage could not be determined. The reported patient effect of hemorrhage is listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report that during the procedure, the steerable guide catheter (sgc) could have contributed to bleeding in the femoral artery requiring artery repair. It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4 with a prolapse. The steerable guiding catheter was inserted and advanced without issue. The clip delivery system (cds) was advanced to the mitral valve and grasping was attempted without issue; however, the patient started bleeding out and the abdomen became enlarged. The clip was deployed without leaflet insertion due to the bleeding emergency. After deployment, it was confirmed that the clip was inserted well in both leaflets and was stable; however, the patient was continued bleeding and mr remained at 4 but better than the initial mr grade. It was informed, that the patient had a stent placed 2 days before and was on a high dose of plavix of 600mg which contributed to the bleeding. Blood transfusion was performed. In the physician's opinion, the sgc could have put pressure on that femoral artery causing the bleed. The patient continued to bleed post procedure and was sent to for artery repair. No additional information was provided.

• Brand Name: 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: 9744686
• MDR Text Key: 181813478
• Report Number: 2024168-2020-01718
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/26/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 90726U102
• 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: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2019
• 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: 02/24/2020 Patient Sequence Number: 1