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

Catalog Number UNK SGC

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

Patient Problem Perforation (2001)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event dates estimated.The udi number is not known as the part and lot numbers were not provided.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional issues reported in the article are captured under separate medwatch reports.Attachment: report titled "the coapt secondary mr post-approval study annual progress report 2023"na.

Event Description

It was reported the coapt post-approval study (pas) is a prospective, single arm, multi-center, observational real-world surveillance plan to confirm the long-term safety and effectiveness of the mitraclip¿ system in hf patients with smr.The annual follow-up data identified an atrial septal defect requiring closure was obtained by linkage to the cms fee-for-service (ffs) claims database.Additional information was be found in the attached report, titled ¿the coapt secondary mr post-approval study annual progress report 2023.¿.

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 perforation could not be determined.The reported perforation is listed in the instructions for use (ifu) and is a known possible complication associated with mitraclip procedures.The reported medical intervention was the results of case-specific circumstances.There is no indication of a product quality 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: 16569582
• MDR Text Key: 312200433
• Report Number: 2135147-2023-01243
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

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 SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/18/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 04/11/2023
• 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 Age: 72 YR
• Patient Sex: Male