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

Model Number N/A

Device Problems Positioning Failure (1158); Migration or Expulsion of Device (1395); Expulsion (2933)

Patient Problems Endocarditis (1834); Mitral Valve Stenosis (1965); Foreign Body In Patient (2687); Embolism/Embolus (4438); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 07/01/2009

Event Type  Injury  

Manufacturer Narrative

The devices will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Dates estimated.The udi number is not known as the part and lot number were not provided the additional malfunctions reported in the article are captured under a separate medwatch report number.

Event Description

This is filed to report all serious injuries listed in the article.This research article was a retrospective study designed to determine the impact of tricuspid regurgitation (tr) severity and right ventricular (rv) dysfunction on mitral valve (mv) surgery after transcatheter edge-to-edge repair (teer).The study included patients who underwent mv surgery from july 2009 to july 2020 after teer was performed using a mitraclip device.Complications identified in the study included: atrial septal defect (asd) closure, single leaflet device attachment (slda), migration, positioning failure, expulsion, device embolization, mitral stenosis, leaflet injury, endocarditis, recurrent mitral regurgitation (mr), hospitalization and surgical intervention.In conclusion, moderate or greater pre-teer tricuspid regurgitation was associated with worse outcomes, and pre-teer tricuspid regurgitation worsened significantly at mitral valve surgery.Details are listed in the attached article titled, " impact of tricuspid regurgitation on outcomes of mitral valve surgery after transcatheter edge-to-edge repair".

Manufacturer Narrative

The devices were not returned for analysis.The lot history record review and lot specific similar complaint review were not performed because this complaint is based on an article, and no part or lot information was provided.Based on available information, causes for the reported incomplete coaptation, positioning failure, expulsion, and migration could not be determined.The reported mr, leaflet injury, foreign body in patient, and embolism appear to be cascading effects of the incomplete coaptation, expulsion, and migration.Causes for the reported mitral stenosis and endocarditis could not be determined.Additionally, the reported patient effects of mr, mitral stenosis, tissue damage, endocarditis, foreign body in patient, and embolism are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalizations and surgeries were the results 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: 15366344
• MDR Text Key: 299356105
• Report Number: 2135147-2022-01025
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

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 Model Number: N/A
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/24/2022
• 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): Disability; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male