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

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6)2023 a mitraclip was implanted.On (b)(6)2023 a transthoracic echocardiogram (tte) was performed, and limited views suggested a single leaflet device attachment (slda).

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided the device was not returned for analysis and a review of the lot history record and similar complaint could not be performed as the lot information regarding the complaint device was not provided.The investigation was unable to determine a cause for the slda.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: 18660072
• MDR Text Key: 334772566
• Report Number: 2135147-2024-00552
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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 CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/12/2024
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 64 KG