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); Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Sepsis (2067); Regurgitation, Valvular (2335); No Code Available (3191)

Event Date 12/06/2017

Event Type  Injury  

Manufacturer Narrative

Citation: cabalka ak et al.Transcatheter pulmonary valve replacement using the melody valve for treatment of dysfunctional surgical bioprostheses: a multicenter study.J thorac cardiovasc surg.2018 apr;155(4):1712-1724.E1.Doi: 10.1016/j.Jtcvs.2017.10.143.Epub 2017 dec 6.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the safety and effectiveness of melody valve function in patients who underwent transcatheter pulmonary valve replacement (tpvr) into a dysfunctional pulmonary bioprosthetic valve (bpv).All data were collected from 10 centers between january 2010 and june 2015.The study population included 100 patients (predominantly male; mean age 22 years; mean weight 62 kg), all of which were implanted with a medtronic melody transcatheter pulmonary valve, and 20 of which had a previously implanted medtronic hancock bioprosthetic valve or a medtronic mosaic bioprosthetic valve in the pulmonary position.No serial numbers were provided.Among all patients, adverse events included: valve-in-valve implantation (melody valve placed into dysfunctional surgical bpv), 1 case of streptococcus viridans endocarditis with sepsis 18 months following tpvr procedure, pulmonary stenosis, severe pulmonary regurgitation, moderate obstruction, high right ventricular outflow tract gradients, and 1 case of vascular access site bleeding requiring transfusion and surgical repair of a femoral arteriovenous fistula and pseudoaneurysm 6 weeks after tpvr procedure.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7695785
• MDR Text Key: 114287581
• Report Number: 2025587-2018-01774
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• 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: 08/08/2018
• 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: 22 YR
• Patient Weight: 62