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 Hemorrhage/Bleeding (1888); Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) and similar incident reviews were not performed because no lot information was provided.Based on available information and due to the limited information available from the article, the cause of the reported heart failure, renal failure, hemorrhage, and recurrent mr were unable to be determined.The reported patient effects of heart failure, hemorrhage, mitral regurgitation, and renal failure, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Date of event is estimated.The udi number is not known as the part and lot numbers were not provided.The implant date is estimated.Attachment: article titled ¿impact of extra-mitral valve cardiac involvement in patients with primary mitral regurgitation undergoing transcatheter edge-to-edge repair.¿.

Event Description

It was reported through a research article that 654 patients underwent transcatheter edge-to-edge repair (teer) from (b)(6) 2020.Within two years of the procedure, the implanted mitraclips may have caused or contributed to recurrent mitral regurgitation, acute heart failure, acute kidney injury, bleeding, intervention to implant an additional mitraclip, and rehospitalization.Additional information is listed in the attached article, ¿impact of extra-mitral valve cardiac involvement in patients with primary mitral regurgitation undergoing transcatheter edge-to-edge repair.¿.

• 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: 18243467
• MDR Text Key: 329430921
• Report Number: 2135147-2023-05281
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/30/2023

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: 11/09/2023
• Initial Date FDA Received: 11/30/2023
• 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: 81 YR
• Patient Sex: Male