MAUDE Adverse Event Report: HEART VALVES SANTA ANA FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pericardial Effusion (3271); Heart Block (4444)

Event Date 03/29/2021

Event Type  Injury  

Event Description

Medtronic received information via literature regarding the outcomes for patients implanted with a freestyle aortic root to treat severe necrotizing endocarditis.All data were collected from a single center between january 2000 and december 2018.The study population included 45 patients (predominantly male, mean age 70.9 years) all with active infective endocarditis.All patients were implanted with a medtronic freestyle aortic root bioprosthesis (unique device identifier numbers not provided).Among all patients, 7 deaths occurred within 30 days of implant.One patient presented with hemorrhagic pericardial effusion due to fistula which required complex patch repair and neoannulus reconstruction.After weaning from cardiopulmonary bypass (cpb) the patient developed severe hemorrhage and died peri-operatively.Other early deaths were caused by septic multiorgan failure, mesenteric ischemia, and low cardiac output-syndrome.The physician/authors noted severe sepsis as a predictor of 30-day mortality.During a follow-up with a mean of 3.6 years there were 19 deaths.Patients with concomitant surgeries were a predictor for late mortality.No further details were provided on the deaths.Based on the available information medtronic product had no causal or contributory relationship with the deaths.Among all patients, adverse events included: complete heart block with implant of a permanent pacemaker, bleeding requiring intervention, hemorrhagic pericardial effusion, and staphylococcal infection.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

Citation: hansen et al.The freestyle valve in severe necrotizing aortic root endocarditis: comorbidity upon outcome.Thorac cardiovasc surg.2021 mar 29.Doi: 10.1055/s-0040-1722652.Earliest date of publish used for date of event.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.

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: 1) that medtronic product did not cause or contribute to the observed adverse events, 2) unique device identifiers were not available, 3) no products were available for return, and 4) the mean weight of the study population was 77.7 kg.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12756229
• MDR Text Key: 281742888
• Report Number: 2025587-2021-03353
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2021
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG