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

Model Number 40023

Device Problems Gradient Increase (1270); Dent in Material (2526); Scratched Material (3020); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 06/25/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product was returned, but the analysis has not yet begun.Once the analysis is completed, a supplemental report will be filed.Conclusion: without completed analysis 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 immediately post implant of this 23mm bioprosthetic aortic valve, it was reported that there was a gradient of 33mmhg.The original sternotomy was enlarged, and the valve was explanted and replaced with a non-medtronic valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, visual inspection revealed the valve was discolored with small needle holes noted on the sewing ring, which indicated evidence of blood contact and implantation sutures.All leaflets were in the closed position with moderate gaps between the coaptive ridges and the free margins of all leaflets.All leaflets were slightly stiff but flexible.Leaflets 1 (l1) and 2 (l2) were qualitatively stiffer than leaflet 3 (l3).All leaflets appeared thickened and desiccated.Serrated imprints, approximately 9mm in length, were observed on the outflow and inflow aspects of l1.Multiple additional serrated imprints were observed on the outflow aspect of l3.These imprints were likely attributed to tools used during explant, such as forceps.There was an approximate 4mm cut/tear adjacent to the imprints on l1.Damage to the tissue was noted on l1 nearing post 3 (p3).An indentation was noted on the outflow belly aspect of l2, approximately 5.5mm in length.Remnant host tissue was noted on post 2 (p2) and p3.Post 1 (p1) appeared intact.Host tissue seated on the outflow margin of attachment of all leaflets was observed.Conclusion: due to the desiccated condition of the valve upon receipt, an accurate evaluation of its flow characteristics was unable to be demonstrated through in-vitro evaluation.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 analysis of the returned valve noted damage to the tissue that most likely occurred during the explant procedure.In addition, this valve was evaluated through the mini pulse system which showed that the valve leaflets opened fully and had complete coaptation upon closure.Based on the reported information and device analysis, a conclusive cause of the high gradients could not be determined.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: 8820990
• MDR Text Key: 152015824
• Report Number: 2025587-2019-02317
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 40023
• Device Catalogue Number: 40023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 99