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

Catalog Number UNK CDS

Device Problem Incomplete Coaptation (2507)

Patient Problems Stroke/CVA (1770); Perforation of Vessels (2135); Heart Failure/Congestive Heart Failure (4446); Unspecified Tissue Injury (4559)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.D6 - the implant date is estimated.The additional patient effect of death reported in the article is 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 slda, death, tissue injury, perforation, cerebrovascular accident, and heart failure.Death, tissue injury, perforation, cerebrovascular accident, and heart failure are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported unexpected medical intervention and hospitalization were results of case specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.Attachment: article titled "one-year outcomes and their relationship to residual mitral regurgitation after transcatheter edge-to-edge repair with mitraclip device: insights from the ocean-mitral registry.".

Event Description

This research article was a retrospective study designed to evaluate clinical outcomes relating to residual mitral regurgitation at discharge after mitral valve transcatheter edge to edge repair (teer).Complications identified in the study included: death, leaflet tear, mitral valve reintervention, closure of atrial septal defect, stroke, heart failure hospitalization, and single leaflet device attachment (slda).In conclusion, both residual mr 2+ and 3+/4+ after transcatheter edge-to-edge repair at discharge were associated with worse clinical outcomes compared with residual mr 0+/1+.Details are listed in the attached article titled, "one-year outcomes and their relationship to residual mitral regurgitation after transcatheter edge-to-edge repair with mitraclip device: insights from the ocean-mitral 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: 18056903
• MDR Text Key: 327182949
• Report Number: 2135147-2023-04830
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/02/2023

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?: 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: 10/10/2023
• Initial Date FDA Received: 11/02/2023
• 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): Required Intervention; Hospitalization