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

Model Number 620R

Device Problems Backflow (1064); Partial Blockage (1065); Incomplete Coaptation (2507)

Patient Problems Mitral Regurgitation (1964); Stenosis (2263); Aortic Dissection (2491)

Event Date 11/20/2009

Event Type  Injury  

Manufacturer Narrative

Citation: dibardino, et al.Four decades of experience with mitral valve repair: analysis of differential indications, technical evolution, and long-term outcome.J thorac cardiovasc surg.2010 jan;139(1):76-83; discussion 83-4.Doi: 10.1016/j.Jtcvs.2009.08.058.Pmid: 19931098.Available ahead of print nov 20, 2009.Earliest date of publish used for event date.Medtronic products referenced: duran ancore annuloplasty ring (pma# k960356, product code krh), cg future band annuloplasty ring (pma# k061127, product code krh).Earliest approved product used for product code and pma#.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 regarding long-term outcomes of mitral valvuloplasty performed by a single surgeon over a four-decade period.All data were retrospectively collected from a single center between february 1972 and april 2008.The study population included 1503 patients (predominantly male, mean age 60.3 years), 178 of whom were implanted with medtronic duran ancore annuloplasty rings and 9 were implanted with medtronic cg future annuloplasty rings (no serial numbers provided).Among all patients, overall 30-day mortality was 1.3% with operative mortality by decade at 0% in the 1970s, 1.8% in the 1980s, 1.4% in the 1990s and 1.1% in the 2000s.No further information was provided.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: acute dissection of the ascending aorta, moderate-severe mitral regurgitation and moderate-severe mitral stenosis requiring surgical correction, severe systolic anterior leaflet motion after repair requiring surgical correction.Based on the available information medtronic product may have been associated with the adverse events.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: 10485076
• MDR Text Key: 205484176
• Report Number: 2025587-2020-02732
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960356
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 08/13/2020
• 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 Age: 60 YR