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

Model Number 30519

Device Problems Inadequacy of Device Shape and/or Size (1583); Obstruction of Flow (2423)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

Citation: brinkmann c et al.Bioprosthetic valve fracture can eliminate pre-existing prothesis-patient mismatch.Journal of the american college of cardiology.2019 oct;74(13):suppl b34.Doi: 10.1016/j.Jacc.2019.08.062.Epub 2019 sep 25.Earliest date of publish used for event date.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 the 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 an evaluation of whether bioprosthetic valve fracture (bvf) can safely eliminate pre-existing prosthesis-patient mismatch in patients with degenerated aortic bioprostheses.All data were collected from 12 centers.The study population included 43 patients (predominantly female; mean age 75 years), approximately 10 of which previously underwent surgical aortic valve replacement (savr) with medtronic mosaic bioprosthetic valves and 27 underwent valve-in-valve transcatheter aortic valve replacement (viv-tavr) with medtronic evolut r bioprosthetic valves.No serial numbers were provided.Bvf was reported to be performed with non-compliant balloons either prior or after viv-tavr.Complications following viv-tavr were defined according to valve academic research consortium-2 criteria.Among all patients, one death occurred following balloon rupture.No other details were provided.Multiple manufacturers were noted in the literature; based on the available information, medtronic product was not directly associated with the death.Among all savr patients, adverse events included: viv-tavr due to stenosis, regurgitation, or a combination of both.Moderate-severe prosthesis-patient mismatch was also noted.Based on the available information, medtronic product was directly associated with the adverse events.Among all viv-tavr patients, adverse events included: one patient had a ventricular septal perforation after bvf with a 4 mm oversized balloon (manufacturer not identified).It was reported that this patient had aortic root calcification and a porcelain aorta.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.

Manufacturer Narrative

Additional information received from the physician/author stated that medtronic product did not cause or contribute to the observed adverse events.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: 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
• MDR Report Key: 9247825
• MDR Text Key: 176070611
• Report Number: 2025587-2019-03298
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P990064
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• 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
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR