MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP MITRAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500DM

Device Problem Perivalvular Leak (1457)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Regurgitation, Valvular (2335); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

Citation: baotong li et al.Mitral valve annuloplasty versus replacement for severe ischemic mitral regurgitation.Sci rep.2018 jan 24;8(1):1537 doi: 10.1038/s41598-018-19909-7.Epub 2018 jan 24.Earliest date of publish used for event 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 the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a long-term analysis evaluating the effectiveness of mitral valve annuloplasty versus mitral valve replacement for severe chronic ischemic mitral regurgitation.All data were collected from a single center between january 2002 and april 2017.The study population included 436 patients (predominantly male; mean age 60 years), an undisclosed number of which were implanted with a medtronic mosaic bioprosthetic valve, a medtronic hancock ii bioprosthetic valve, a medtronic duran ancore annuloplasty ring, or a medtronic open pivot mechanical valve.No serial numbers were provided.Among all patients, 63 deaths occurred during the study follow-up period (median follow-up was 59 months).Of these, 50 patients died due to cardiovascular causes.Multiple manufacturers were noted in the literature; based on the available information, medtronic product did not cause or contribute to these deaths.Among all patients, adverse events included: stroke, reoperation for bleeding, use of postoperative intra-aortic balloon pump, moderate-severe mitral regurgitation, periprosthetic leak, and low left ventricular ejection fraction.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between medtronic product and the observed adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Additional information received from the physician/author stated that medtronic product did not cause or contribute to the observed adverse events.If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN PIVOT AP MITRAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8108476
• MDR Text Key: 128556872
• Report Number: 3008592544-2018-00056
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500DM
• Device Catalogue Number: 500DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• 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: 60 YR