MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC

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

Patient Problem Perforation (2001)

Event Date 12/27/2012

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The udi number is not known as the part and lot numbers were not provided the implant date is estimated.The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the cause of the perforation (atrial: percutaneous intervention) associated with the asd could not be determined.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled, "five-year follow-up after transcatheter repair of secondary mitral regurgitation".

Event Description

This research article was a meta-analysis study designed to evaluate data from a 5-year follow-up of outcomes after transcatheter edge-to-edge repair of severe mitral regurgitation, as compared with outcomes after maximal doses of guideline-directed medical therapy alone.Complications identified in the study included: single leaflet device attachment, expulsion, heart failure, hospitalization due to heart failure, mitral valve replacement surgery, new pacemaker implanted, heart transplantation, left ventricular assist device, stroke, atrial fibrillation, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, embolism, foreign body in patient, atrial septal defect that required intervention, cardiovascular death, non-cardiovascular death.In conclusion, among patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation who remained symptomatic despite guideline-directed medical therapy, transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality through 5 years of follow-up than medical therapy alone.Details are listed in the attached article titled, "five-year follow-up after transcatheter repair of secondary mitral regurgitation".

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• 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: 16689245
• MDR Text Key: 312775394
• Report Number: 2135147-2023-01488
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2023

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?: No
• 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: 03/15/2023
• Initial Date FDA Received: 04/06/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male