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

Catalog Number UNK SGC03

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

Patient Problem Perforation (2001)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

The devices were not returned for analysis. A review of the lot history record could not be performed as this incident was based on tvt registry data, and no device/lot information was provided. Based on available information, causes for the reported atrial perforation could not be determined. Furthermore, the reported patient effect of atrial perforation is listed in the mitraclip instructions for use (ifu) as a known possible complication associated with mitraclip procedures. The reported unexpected medical interventions were the result of case-specific circumstances. There is no indication of a product issue with respect to manufacture, design, or labeling. Date of event, implant/explant date: dates estimated.

Event Description

It was reported through transcatheter valve therapy (tvt) registry data that mitraclip devices may be related to 3 perforation (atrial septal defect) requiring intervention adverse 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. Tvt registry data is reported as a summary per summary reporting exemption approval number - e2015009. No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• 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: 13004511
• MDR Text Key: 287412731
• Report Number: 2024168-2021-11568
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• 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 Treatment Data

Date Received: 12/14/2021 Patient Sequence Number: 1