MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM SEGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, out of 123 patients implanted with a valve-in-ring procedure, 10 were implanted with an abbott ring.Complications post-procedure included device embolization and surgical intervention.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 through a research article identifying abbott rings that may be related to a complications post procedure.Details are listed in the article, titled "thirty-day outcomes of transcatheter mitral valve replacement for degenerated mitral bioprostheses (valve-in-valve), failed surgical rings (valve-in-ring), and native valve with severe mitral annular calcification (valve-in- mitral annular calcification) in the united states." it was reported in the article that 123 patients underwent mitral valve-in-ring procedure between march 2013 and june 2017 in 172 facilities, with 10 of the rings implanted to be an abbott ring.The median age was 73 years old.59 of the patients were female.The patients have the following comorbidities: diabetes, atrial fibrillation, chronic kidney disease, severe lung disease and stroke.Complications post procedure includes: device embolization and unplanned surgical intervention.

• Brand Name: SJM SEGUIN SEMI-RIGID ANNULOPLASTY RING
• 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: 9918524
• MDR Text Key: 189572705
• Report Number: 2648612-2020-00044
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/02/2020
• 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): Required Intervention
• Patient Age: 73 YR