MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING; RING, ANNULOPLASTY

Model Number 620R

Device Problem Backflow (1064)

Patient Problem Mitral Regurgitation (1964)

Event Date 01/26/2009

Event Type  Injury  

Manufacturer Narrative

Citation: silberman s., et al.Repair of ischemic mitral regurgitation: comparison between flexible and rigid annuloplasty rings.Ann thorac surg.2009 jun;87(6):1721-6; discussion 1726-7.Doi: 10.1016/j.Athoracsur.2009.03.066.Presented at the forty-fifth annual meeting of the society of thoracic surgeons, san francisco, ca, jan 26¿28, 2009.Earliest date of publish used for event date and death date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature comparing outcomes of surgical repair of ischemic mitral regurgitation using rigid versus flexible annuloplasty rings.All data were collected from a single center between 1995 and 2006.The study population included 169 patients (predominantly male, mean age 65 years), 117 of whom were implanted with medtronic duran ancore annuloplasty rings (no serial numbers provided).Among all medtronic duran ancore patients, 10 post-operative deaths occurred, due to unspecified cardiac causes, sepsis and strokes.Based on the available information, medtronic product may have been associated with the deaths.Over the course of long-term follow-up, 32 more medtronic duran ancore patients died, but no further information was provided regarding those deaths.Based on the available information, medtronic product was not directly associated with those deaths.Among all medtronic duran ancore patients, adverse events included: recurrent moderate-severe mitral regurgitation.Based on the available information, medtronic product was directly associated with the adverse event.No additional adverse patient effects or product performance issues were reported.

• Brand Name: DURAN ANCORE RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10172214
• MDR Text Key: 200997468
• Report Number: 2025587-2020-01963
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K960356
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 620R
• Device Catalogue Number: 620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/18/2020
• 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): Other
• Patient Age: 65 YR