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 Aneurysm (1708); Endocarditis (1834); Vascular Dissection (3160)

Event Date 07/17/2021

Event Type  Death  

Manufacturer Narrative

Citation: dagnegard et al.Survival after aortic root replacement with a stentless xenograft is determined by patient characteristics.J thorac cardiovasc surg.2021 jul 17;s0022-5223(21)01042-4.Doi: 10.1016/j.Jtcvs.2021.07.011.Earliest date of publish used for date of event and date of death.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 survival after aortic root replacement with a stentless xenograft.All data were collected from six centers from 1999 to 2018.The study population included 1,008 patients (predominantly male, median age 68 years).All patients were implanted with a medtronic freestyle aortic root xenograft prosthesis (unique device identifier numbers not provided).Among all patients, 67 deaths occurred within 72 hours of implant.Causes of death included endocarditis (n=27),type a dissection (n=24), aneurysm (n=3), and other causes (n=13).At 30- and 90-day follow-up, there were 105 and 127 deaths, respectively.The physician/authors postulated that survival after aortic root replacement was determined by the patient condition, not the characteristics of the prosthesis.Still, based on the available information, medtronic product was reasonably associated with the early death(s) within 72 hours of implant.Among all patients, adverse events included: endocarditis, myocardial infarction (mi), unspecified structural valve dysfunction (svd), tamponade or bleeding complications, kink of the proximal coronary or other ostial obstruction, and stroke.Most of these observations required intervention to treat.Based on the available information medtronic product was associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• 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: 12741754
• MDR Text Key: 279771120
• Report Number: 2025587-2021-03316
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P970031
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• 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?: Yes
• Date Manufacturer Received: 10/25/2021
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR