MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

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

Patient Problem Death (1802)

Event Date 06/29/2016

Event Type  Death  

Manufacturer Narrative

Outcomes to adverse event, date of event, implant date: dates estimated.The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This is filed to report death.It was reported through a research article that 24 patients underwent a mitraclip procedure to treat functional mitral regurgitation (mr).Within three years of the mitraclip procedure, it was reported that the implanted clips may have caused or contributed to death.Details are listed in the attached article, titled ¿minimally invasive mitral valve repair for functional mitral regurgitation in severe heart failure: mitraclip versus minimally invasive surgical approach.¿ no additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis.Additionally, a review of the lot history record and complaint history for the reported lot could not be conducted, because the lot number and serial numbers were not provided.All available information was investigated and the reported death appear to be due to procedural circumstance/operational context.Death is listed in the mitraclip system instructions for use as a known possible complication associated with mitraclip procedures.There is no indication of product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11404509
• MDR Text Key: 234435304
• Report Number: 2024168-2021-01658
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/10/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death