MAUDE Adverse Event Report: HEART VALVES SANTA ANA MEDTRONIC SURGICAL TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MDT-TISSUE VALVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aortic Valve Stenosis (1717); Hemorrhage/Bleeding (1888); Rupture (2208); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 04/01/2010

Event Type  Injury  

Manufacturer Narrative

Citation: vezmar et al.Percutaneous pulmonary valve implantation in the young: 2-year follow-up.Jacc cardiovasc interv.2010 apr;3(4):439-48.Doi: 10.1016/j.Jcin.2010.02.003.Earliest date of publish used for event date.Medtronic products referenced: hancock conduit (pma# p790007, product code lwr), hancock valve (pma# p870078, 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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the physiological and clinical consequences of percutaneous pulmonary valve implantation (ppvi) in patients with chronic right ventricular outflow tract (rvot) obstruction and volume overload.All data were collected from a single center between october 2005 and december 2008.The study population included 28 patients (predominantly male, mean age 14.9 years, mean weight (b)(6) kg).Multiple manufacturer¿s devices were implanted in the study population; medtronic products included melody (n=28), hancock conduit (n = 10) and hancock bioprosthetic valve (n=6).No serial numbers were provided.Among all patients adverse events included: one conduit disruption after balloon dilation in which the tear was sealed by the valve implant; one local arterial aneurysm which resolved with ultrasound guided compression; post-implant aortic systolic pressure increased; right ventricle to pulmonary artery high gradients (>60 mm hg); moderate pulmonary regurgitation/insufficiency; recurrent stenosis/obstruction; branch pulmonary artery obstruction requiring conduit replacement; and other unspecified reoperation/reintervention for pulmonary valve replacement.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

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.

Event Description

Additional information received from the physician/author stated that unique device identifiers were unknown and that no medtronic devices were available for return.

• Brand Name: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11159902
• MDR Text Key: 227576294
• Report Number: 2025587-2021-00147
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Life Threatening; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 58