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 Stroke/CVA (1770); Intracranial Hemorrhage (1891)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

This will be filed as a serious injury summary report per fda exemption approval number - e2015009.Product performance engineering reviewed the incident information; however, a failure analysis of the complaint device could not be performed because the product 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 intracranial hemorrhage and cerebrovascular accident, as listed in the mitraclip system electronic instructions for use (ifu), are known possible complications associated with mitraclip procedures.A conclusive cause for the reported intracranial hemorrhage and cerebrovascular accident could not be determined.

Event Description

It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 3 intracranial hemorrhage and cerebrovascular accident events which are considered serious injury.The relationship of the adverse events to the mitraclip device could not be determined based on the limited data received from the registry.Patients¿ mean age 70 years, ranging from 62 - 81 years.67% patients were male, 33% patients were female.This will be filed by 7/31/2020 as a serious injury 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: 10271517
• MDR Text Key: 198861566
• Report Number: 2024168-2020-05773
• 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: 07/14/2020

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: 07/14/2020
• 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): Other
• Patient Age: 73 YR