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

Model Number T505

Device Problems Partial Blockage (1065); Reflux within Device (1522)

Patient Problems Tricuspid Valve Stenosis (2113); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 05/09/2022

Event Type  Injury  

Event Description

Medtronic received information via literature regarding treatment of bioprosthetic tricuspid structural valve deterioration (svd).All data were prospectively collected from a single center between february 2014 and june 2018.The study population included twelve patients who were predominantly male with a mean age of 65 years.Multiple manufacturer¿s devices were implanted in the study population; four patients were previously implanted with a medtronic hancock ii tricuspid bioprosthesis.No unique device identifier numbers were provided.All patients required transcatheter valve-in-valve (viv) implantation of a balloon-expandable bioprosthetic valve as treatment for svd.Among all patients, four deaths occurred over a four-year follow-up period, due to malignancy, infections,and unknown causes.There was no statement of causal or contributory relationship between medtronic product and the deaths.Among all medtronic hancock ii patients, adverse events included: structural valve deterioration (svd) resulting in mixed severe tricuspid stenosis/regurgitation.The patients required surgical valve interventions and transcatheter valve-in-valve (viv) implantation of a balloon-expandable bioprosthetic valve.Based on the available information medtronic product was associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: schamroth pravda n.;et al.Tricuspid structural valve deterioration treated with a transcatheter valve-in-valve implantation: a single-center prospective registry.J.Clin.Med.2022, 11, 2667.Https://doi.Org/10.3390/jcm11092667.Pmid: 35566791.Published 09 may 2022.Earliest date of publication used for date of event.Medtronic products referenced: hancock ii (pma# p980043, product code: dye).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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II AORTIC 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15966675
• MDR Text Key: 305342347
• Report Number: 2025587-2022-03522
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• 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
• Treatment: UNKNOWN IPG, UNKNOWN ICD
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male