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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Transient Ischemic Attack (2109)

Event Date 12/11/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record (lhr) and corrective action tracking system for the web (catsweb) database for the reported lot could not be performed as the lot number and part number are unknown.Based on the information reviewed, and due to limited information available from the article the cause for the reported bleeding, cerebrovascular accident, transient ischemic attack, and myocardial infarction (mi) could not be determined.Additionally, the reported patient effects of bleeding, cerebrovascular accident, transient ischemic attack, and myocardial infarction (mi) are listed in the instructions for use, and are known possible complications associated with mitraclip procedures.The reported medical intervention was the result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B3: date of event estimated.D4: the udi is unknown due to the part/lot number was not provided.D6: date of implant estimated.Attachment: article titled ¿bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: results from an all-comers national registry.¿.

Event Description

It was reported through a research article that 322 patients underwent transcatheter edge-to-edge mitral valve repair (teer) from 2011 to 2021.Within 3 months of the procedure, the implanted mitraclip may have caused or contributed to bleeding, blood transfusion, stroke, transient ischemic attack (tia) and myocardial infarction (mi).Additional information is listed in the attached article, titled, ¿bleeding and thrombotic risk of different antiplatelet regimens posttranscatheter edge-to-edge mitral valve repair in patients with an indication for oral anticoagulation: results from an all-comers national registry.¿.

• 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: 18445165
• MDR Text Key: 331911869
• Report Number: 2135147-2024-00053
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/04/2024

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: 12/12/2023
• Initial Date FDA Received: 01/04/2024
• 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): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female