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 11/02/2020

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is being filed to report the thrombus.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Five minutes after the steerable guide catheter (sgc) inserted into the groin, and the dilator and guide wire were retracted, while aspirating the sgc, a thrombus was noted at the hemostasis valve.The physician attempted to aspirate the thrombus but was unsuccessful the thrombus stayed in the hemostasis valve and was stable there but the risk to mobilize it was too high.Therefore, the sgc was removed and exchanged for a new sgc.After the first sgc was removed, there was no evidence of thrombus or something similar inside the patients heart or any other structure.The patient had heparin for bridging medication as an anticoagulation prior to the procedure.Activated clotting time (act) was 268 at the time when the thrombus was noted.One clip was implanted, reducing mr to 1-2.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 issued to the reported lot that would have contributed to the reported event.Based on the available information, a cause for the reported thrombosis could not be determined.The reported patient effect of thrombosis is listed in the mitraclip system instructions for use (ifu), and is a known possible complication associated with mitraclip procedures.The reported additional therapy/non-surgical treatment and treatment with medication were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10889479
• MDR Text Key: 217926442
• Report Number: 2024168-2020-09832
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• 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: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00806U204
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR