MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, REPLACEMENT

Model Number 30519

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888)

Event Date 06/24/2017

Event Type  Injury  

Manufacturer Narrative

Citation: kolkailah aa et al.Impact of prosthesis size and prosthesis-patient mismatch on outcomes in younger female patients under going aortic valve replacement.Semin thorac cardiovasc surg.2020 summer;32(2):219-228.Doi: 10.1053/j.Semtcvs.2019.01.005.Epub 2019 jan 7.Presented at the western thoracic surgical association 43rd annual meeting in colorado springs, colorado - june 24, 2017.Date of presentation 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.

Event Description

Medtronic received information from a literature article regarding the clinical outcomes of younger females who underwent surgical aortic valve replacement and an assessment of the incremental risk of patient-prosthesis mismatch.All data were retrospectively collected from a single center between january 2002 and june 2015.The study population included 451 female patients with a mean age of 55 years.Of those, 4 patients were implanted with medtronic mosaic surgical aortic valves.No serial numbers were provided.Among all patients, 61 deaths occurred during the observation period of approximately 14 years.Multiple manufacturers valves were implanted in the study population.None of the deaths were directly associated with medtronic product.Among all patients, adverse events included: intra-operative intra-aortic balloon pump support, patient-prosthesis mismatch, required post-operative ventilation for more than 24 hours, need for red blood cell transfusion (mean units of blood: 2), need for reoperation, permanent stroke, and unspecified need for hospital readmission within 30 days after valve implant.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, REPLACEMENT
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 10864392
• MDR Text Key: 217452906
• Report Number: 2025587-2020-03572
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30519
• Device Catalogue Number: 30519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2020
• 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): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 55 YR