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

Catalog Number UNK CDS

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Hemorrhage/Bleeding (1888)

Event Date 05/22/2023

Event Type  Injury  

Event Description

This is filed to report atrial fibrillation, pacemaker, stroke, vascular complication, and bleeding.It was reported through a research article that 330 patients underwent mitral valve (mv) surgery after failed transcatheter edge-to-edge repair (teer) stratified by mitral regurgitation (mr) etiology from july 2009 to july 2020.Thirty days to one year after surgery, the patient outcomes included hospitalization/readmission or prolonged hospitalization, atrial fibrillation, pacemaker implantation, stroke, vascular complication, and bleeding.Additional information is listed in the attached article, titled "impact of mitral regurgitation etiology on mitral surgery after transcatheter edge-to-edge repair.".

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 was not provided.Based on the information reviewed and due to the limited information available from the article and the article covering multiple patients, a cause for the reported hemorrhage, atrial fibrillation, and cerebrovascular accident/stroke cannot be determined.However, hemorrhage, atrial fibrillation, and cerebrovascular accident/stroke are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention and hospitalization were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.B3: date of event is estimated.D4: the udi number is not known as the part and lot numbers were not provided.D6: the implant date is estimated.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17192175
• MDR Text Key: 317815810
• Report Number: 2135147-2023-02724
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2023

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: 06/02/2023
• Initial Date FDA Received: 06/23/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female