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

Catalog Number UNK CDS

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

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982)

Event Date 05/14/2020

Event Type  Death  

Manufacturer Narrative

Dates of death, event, and implant: dates estimated.This will be filed as a death summary report per fda exemption approval number - e2015009.The device was not returned for analysis.A review of the lot history record could not be performed due to unknown lot information.The reported patient effects of patient death and neurological deficit/dysfunction as listed in the mitraclip system electronic instructions for use (ifu) are known possible complications associated with mitraclip procedures.Based on the limited information reviewed, conclusive causes for the reported patient death and neurological deficit/dysfunction could not be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 1 death event with the clarifier non-cardiovascular and neurological deficit dysfunction.The relationship of the death to the mitraclip device could not be determined based on the limited data received from the registry.Patient's age 66 years, female.This will be filed by 7/31/2020 as a death summary report per fda exemption approval number - e2015009.No additional information was provided.

• Brand Name: MITRACLIP CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10276629
• MDR Text Key: 198900609
• Report Number: 2024168-2020-05837
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR