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

Model Number 305U2J19

Device Problems Calcified (1077); Gradient Increase (1270); Material Separation (1562); Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Corneal Pannus (1447)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

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 immediately post implant of this bioprosthetic aortic valve, patient-prosthesis mismatch was suspected.Approximately 10 years post implant, the valve was explanted and replaced with another bioprosthetic valve.Upon explant, pannus was noted on the inflow portion of the valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Added patient date of birth in age or date of birth added patient weight in weight.Corrected implant date in implant date.Updated device availability status in concomitant medical products.Updated device evaluated by mfr.Updated evaluation method code in updated evaluation result code in the device has been returned and is pending product analysis.A supplemental report will be filed once the analysis is complete.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Manufacturer Narrative

Medtronic received additional information that prior to explant of this valve, the maximum pressure gradient was 57 mmhg and mean gradient was 35 mmhg.The valve was replaced with a non-medtronic bioprosthetic valve.No additional adverse patient effects were reported.  device code was updated.Evaluation conclusion code was 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.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed that the sewing ring was damaged, which likely occurred during the explant procedure.The valve was slightly distorted.All leaflets were in the closed position with wavy free margins.All leaflets were slightly stiff but flexible except where host tissue was present.The free margins of all cusps were twisted.Tissue deterioration was noted on the left (lc) and right cusps (rc) what is likely a result of the commissure dehiscence.Multiple abrasions were seen through the free margin and lunula of the right cusp (rc).A fold was noted on the free margin of the non-coronary (nc) cusp.The right left commissure was dehisced and possibly related to the separation of layers of aortic wall behind the commissure.The condition of the manufacturing sutures holding the aortic wall to the stent post could not be seen.The right non-coronary commissure was intact.The left non-coronary commissure exhibited the start of separation of the non-coronary (nc) aortic wall layers.Thick tan-white pannus lined the inflow, and extended from the base stitching encroaching up to 5 mm on the non-coronary (nc) cusp, 6 mm on the right cusp (rc) and 4mm on the left cusp (lc) and into all inferior coaptive areas.Thick glistening off white pannus was on the outflow diameter of the sewing ring.An unknown amount of pannus was removed during explant.Radiologic evaluation revealed marginal calcification on the right cusp (rc), non-coronary aortic wall adjacent to the left non-coronary commissure and left cusp (lc).Conclusion: investigation is ongoing, a supplemental report will be submitted should any new or additional information become available.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.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.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.

Manufacturer Narrative

Added serial number.Added expiration date.Added unique identifier (udi).Added device manufacture date.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.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 PORCINE HEART 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: 8220652
• MDR Text Key: 132195157
• Report Number: 2025587-2019-00076
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2013
• Device Model Number: 305U2J19
• Device Catalogue Number: 305U2J19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 53