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

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Sepsis (2067); Cardiac Tamponade (2226); Cusp Tear (2656); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.The devices were not returned for analysis.A review of the lot history records and the similar complaints review could not be performed as the part and lot information was not provided.Based on the information reviewed, and due to the limited amount of information available and the article covering multiple patients, a cause for the reported incomplete coaptation/slda could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Percutaneous mitral valve repair with mitraclip device in hemodynamically unstable patients: a systematic review.The patient effects and patient deaths reported in the article are filed under different medwatch report numbers.

Event Description

This is filed to report the single leaflet device attachment (slda).It was reported through a research article identifying mitraclip that may be related to the following: patient deaths, leaflet tear, hemorrhage, sepsis, heart failure, cerebrovascular accident, cardiac tamponade, hematoma, unchanged mitral regurgitation, medical intervention, hospitalization, and surgical intervention.Device issues include single leaflet device attachment (slda).Details are listed in the attached article, titled ¿percutaneous mitral valve repair with mitraclip device in hemodynamically unstable patients: a systematic review.¿.Please see article for additional information.

• Brand Name: MITRACLIP SYSTEM 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: 11821804
• MDR Text Key: 253234897
• Report Number: 2024168-2021-04070
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/26/2021
• Initial Date FDA Received: 05/13/2021
• 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 Age: 70 YR