MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. TAILOR FLEXIBLE RING AND BAND; RING, ANNULOPLASTY

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

Patient Problem Mitral Regurgitation (1964)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported through a research article identifying tailor flexible band and seguin semi-rigid ring that may be related to lower durability of mitral repair post-implant if residual mr was more than mild at hospital discharge.Specific patient information is documented as unknown.Details are listed in the attached article, titled "optimal versus suboptimal mitral valve repair: late results in a matched cohort study".It was reported in the article that from 2006 to 2013, a total of 2,158 patients underwent mitral repair for degenerative mitral regurgitation (mr).Of these people, a total of 141 patients were involved in the study with 50 patients in the study group and 91 patients in the control group.The tailor flexible band and the seguin complete semi-rigid ring were involved in the study.No in-hospital deaths were reported.The postoperative course was reported as uneventful.There were no cases of perioperative myocardial infarction, neurological complications, acute renal failure, respiratory failure requiring tracheostomy or need of pacemaker implantation.It was reported that there were 3 late deaths in the study group and 6 deaths in the control group, however none of the deaths were cardiac related.It was reported that 1 patient in the control group required follow up repair.

Manufacturer Narrative

An event of residual regurgitation was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TAILOR FLEXIBLE RING AND BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10075862
• MDR Text Key: 191707900
• Report Number: 2648612-2020-00052
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention