MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T510

Device Problems Gradient Increase (1270); Material Perforation (2205)

Patient Problem Regurgitation, Valvular (2335)

Event Date 06/15/2018

Event Type  Injury  

Manufacturer Narrative

Citation: chezar-azerrad c et al.Iatrogenic atrial septal defect post mitral valve in valve implantation.Cardiovasc revasc med.2018 dec;19(8s):82-85.Doi: 10.1016/j.Carrev.2018.06.010.Epub 2018 jun 15.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a (b)(6) female patient with severe mitral regurgitation who underwent implant of a 27 mm medtronic hancock bioprosthetic valve (serial number not provided).Six months post implant, the patient presented with fever and chills and was hospitalized.During hospitalization, the patient reported having undergone a tooth extraction 10 days prior to admission and six blood culture tests came back positive for corynebacterium striatum.Transthoracic echocardiography exhibited no vegetations and no valvular dysfunction.The patient was diagnosed with endocarditis and was treated with vancomycin for 6 weeks.A follow-up echocardiogram showed mildly elevated gradients and no vegetations.Four months later, the patient presented with pulmonary edema and echocardiography revealed severe mitral regurgitation and a perforation of one of the valve leaflets.Subsequently, a 29 mm non-medtronic bioprosthetic valve was implanted valve-in-valve in the hancock.No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 8299041
• MDR Text Key: 134845100
• Report Number: 2025587-2019-00419
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P980043
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T510
• Device Catalogue Number: T510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• 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: 79 YR