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

Model Number SGC0301

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

Patient Problems Embolism (1829); Thrombosis (2100)

Event Date 05/14/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional two mitraclips devices are filed under a separate medwatch report number.

Event Description

This is filed to report thrombus.It was reported that on (b)(6) 2020, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 4.Prior to procedure, it was noted that the patient had severe barlow¿s disease and a posterior leaflet flail.Three clips were successfully implanted, reducing mr to grade of 1.On a later date, echocardiography was performed and showed mr had increased to a grade of 4.On (b)(6) 2020, a second procedure as performed.At this time, it was confirmed that the first two implanted clip (91206u145, 91206u146) had detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).In an attempt to implant a fourth clip, a steerable guide catheter (sgc) (90723u254) was inserted, but after crossing the septum through the original transseptal puncture, a large thrombus was observed in the right atrium (ra).It was suspected that the thrombus originated in the right femoral vein.After an extensive discussion, the physician decided to proceed with the procedure.However, at this time, the thrombus was no longer visible via transesophageal echocardiogram (tee).It was presumed that the during the discussion, the thrombus had migrated into the right ventricle (rv) or the lungs; however, tee of the rv and pulmonary tree were unable to determine the position of the thrombus.A fourth clip was successfully implanted to stabilize the two slda clips.Mr reduce to a grade of < 1.There was no clinically significant delay in the procedure.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 this event.Based on the information provided a conclusive cause for the reported thrombosis cannot be determined.The reported embolism is the result of the thrombosis.The reported patient effects of thrombosis and embolism, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 10111138
• MDR Text Key: 193419720
• Report Number: 2024168-2020-04669
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 90723U254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP (X3); IMPLANTED MITRACLIP (X3)
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 72