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

Model Number 620R

Device Problems Gradient Increase (1270); Device Appears to Trigger Rejection (1524); Obstruction of Flow (2423)

Patient Problems Host-Tissue Reaction (1297); Dyspnea (1816); Mitral Valve Stenosis (1965)

Event Date 10/19/2005

Event Type  Injury  

Manufacturer Narrative

Citation: bisoi ak et al.Mitral stenosis after duran ring annuloplasty for non-rheumatic mitral regurgitation--a foreign body response? heart lung circ.2006 jun;15(3):189-90.Doi: 10.1016/j.Hlc.2005.08.005.Epub 2005 oct 19.Earliest date of publish used for event date in b3.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 a (b)(6) male patient with a history of myxomatous mitral regurgitation who had undergone mitral valve repair with a 27 mm medtronic duran ancore annuloplasty ring (serial number not provided).At 18 months post-mitral valve repair, the patient presented with dyspnea (new york heart association functional classification iii) and the results of a physical examination were consistent with severe mitral stenosis.The patient¿s mean and end diastolic gradients were noted to be 14 mmhg and 12 mmhg, respectively.Echocardiography showed enlarged left atrium without clots.Subsequently, the duran ancore ring was explanted.During explantation, pannus overgrowth onto the ring was observed.It was reported that histopathological analysis of the ring revealed foreign body giant cell reactions with a neo-myocardial patch surrounding the ring.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: 9355878
• MDR Text Key: 173670759
• Report Number: 2025587-2019-03547
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 620R
• Device Catalogue Number: 620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• 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: 6 YR