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

Catalog Number SGC0302

Device Problem Failure to Advance (2524)

Patient Problem Perforation (2001)

Event Date 11/12/2020

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 filed to report the vein perforation it was reported this was a mitraclip procedure performed to treat functional mitral regurgitation (mr) with a grade of 4.The steerable guide catheter (sgc) did not advance through the tortuous vein and a femoral vein rupture was observed.It is unknown which device caused the vein rupture but the sgc worsened it.A stent was implanted for treatment.The mitraclip procedure was discontinued, no clips were implanted.Mr remained at 4.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.Additionally, a review of the complaint history identified no other complaints reported from this lot.The reported patient effect of venous perforation, as listed in the mitraclip system instructions for use (ifu), is a known possible complication associated with mitraclip procedures.Based on the information provided the reported failure to advance is the result of patient anatomy.A conclusive cause for the reported venous perforation cannot be determined.The reported additional therapy / non-surgical procedure is the result of case specific circumstances as a stent was used to treat the venous perforation.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: 10946297
• MDR Text Key: 219526346
• Report Number: 2024168-2020-10180
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00430U248
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention