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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2024

Event Type  Death  

Manufacturer Narrative

B2 - date of death is estimated.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effects reported in the articles are captured under a separate medwatch report.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported through a research article that 2,236 patients underwent transcatheter edge-to-edge repair (teer) from january 2016 to june 2023.Over several years of the procedure, the implanted mitraclip may have caused or contributed to recurrent mitral regurgitation, bleeding, stroke, myocardial infarction, rehospitalization, and death.Additional information is listed in the attached article, titled ¿transcatheter mitral valve repair with mitraclip: comparison of nt, ntr, and xtr devices.¿.

Manufacturer Narrative

B2 - date of death is estimated.B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.The additional patient effects reported in the articles are captured under a separate medwatch report.The device was not returned for analysis and a review of the lot history record and similar complaint review could not be performed as the part and lot number regarding the complaint device was not provided.The investigation was unable to determine a cause for the reported mr, hemorrhage, cerebrovascular accident, myocardial infarction, and death.Mr, hemorrhage, cerebrovascular accident, myocardial infarction, and death are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported hospitalization was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.

• 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: 19208701
• MDR Text Key: 341330887
• Report Number: 2135147-2024-01894
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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: 04/08/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Female