MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 40023

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

Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 06/07/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this 23mm aortic bioprosthetic valve, it was reported that the narrow sinotubular junction (stj) of the patient did not allow the valve to sit properly on the annulus.It was also reported that "the aorta was torn in two places due to attempted seating of the valve and the right coronary ostia was obstructed by the non deformable frame".The 23mm aortic bioprosthetic valve was explanted and replaced with a non medtronic product.Both barrel and replica ends of the medtronic sizers were used to size the valve and it was this physicians preference to upsize for a larger effective orifice area (eoa).A body surface area (bsa) chart was also used for sizing and indicated a larger valve was needed for this patient.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the sewing ring appeared inverted, and a small tear was noted on the cloth of the sewing ring adjacent to leaflet 1.All leaflets were flexible.A tear was noted on leaflet 3 from the free margin extending to the base of the seam line.A serrated imprint abrasion was noted on the outflow side of leaflet 1 near the base seam line.These damages appeared to have occurred during the explant process.All leaflets appeared to be in the closed position with a gap at the point of coaptation.All commissures appeared intact.A validated production inspection fixture was used to confirm the valve size by assessment of the valve stent post diameter.Analysis confirms the valve size aligns with the requirements for a valve of this size and model.Conclusions: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The returned valve appeared to have damage due to the explant process.The reported issue was that the patient had a narrow sinotubular junction which prevented the valve to be used as intended.No issue was confirmed with the returned valve as the valve size was confirmed with the inspection plate.D9: device available for evaluation? updated h3: device evaluated? updated h6: coding updated 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: AVALUS AORTIC TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12108151
• MDR Text Key: 259650039
• Report Number: 2025587-2021-02073
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983199
• UDI-Public: 00643169983199
• Combination Product (y/n): N
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: 40023
• Device Catalogue Number: 40023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 89