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

Model Number CVD0036

Device Problems Backflow (1064); Biocompatibility (2886); Improper Flow or Infusion (2954)

Patient Problems Atrial Fibrillation (1729); Mitral Regurgitation (1964); Pleural Effusion (2010)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, out of 95 patients implanted with an annuloplasty ring, 10 were implanted with a tailor flexible ring.Complications included 8 patients with low cardiac output syndrome, 2 with a blood transfusion, 1 with a pleural effusion, 2 which required surgical intervention due to bleeding, 8 which had a new onset of atrial fibrillation, 1 patient who required a pacemaker, 3 which needed reoperation due to mitral valve regurgitation and 17 patients who had mitral regurgitation.It was not reported if the patients who experienced complications were implanted with the tailor flexible ring.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported in an article titled, "excellent long-term results with minimally invasive edge-to-edge repair in myxomatous degenerative mitral valve regurgitation¿ that between december 1999 and december 2006, 97 patients with severe myxomatous mitral regurgitation underwent mitral repair.95 patients had an annuloplasty ring implanted with seguin semi rigid ring in 85 patients, and tailor flexible posterior ring in 10 other patients.Complications post procedure included pleural effusion, surgical intervention and blood transfusion due to bleeding, reoperation due to mitral valve regurgitation, new onset of atrial fibrillation, pacemaker implantation, low cardiac output syndrome, and mitral regurgitation during follow up.Additional information was not obtained.

• 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10003091
• MDR Text Key: 189708578
• Report Number: 2648612-2020-00049
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CVD0036
• Device Catalogue Number: CVD0036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2020
• 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): Hospitalization; Life Threatening; Other; Required Intervention