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 Multiple Organ Failure (3261)

Event Date 07/14/2015

Event Type  Death  

Manufacturer Narrative

Event, death, implant dates estimated.The udi is unknown due to the part/lot number was not provided.The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Article attachment.Article title: percutaneous mitral valve repair for acute mitral regurgitation after an acute myocardial infarction.

Event Description

This is filed to report patient death.It was reported through a research article identifying a (b)(6) patient which had a mitraclip procedure after presenting with st-elevation myocardial infarction (stemi) to treat functional mitral regurgitation (mr) with grade 4+.Three clips implanted reducing mr to 2+.However, the patient died of multiorgan failure after 1 week of hospitalization.Details are listed in the attached article, titled percutaneous mitral valve repair for acute mitral regurgitation after an acute myocardial infarction.No additional information was provided.

Manufacturer Narrative

The devices were not returned for analysis and a review of the lot history record could not be performed as the part/lot information regarding the complaint devices were not provided.The investigation determined the reported death was due to patient conditions.Death is listed in the instructions for use (ifu) as known possible complication associated with mitraclip procedures.There is no indication of a 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: 11877715
• MDR Text Key: 252431850
• Report Number: 2024168-2021-04379
• 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: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

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: 05/04/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 06/09/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR