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

Model Number FR995-29

Device Problems Material Frayed (1262); Material Puncture/Hole (1504); Material Rupture (1546); Material Twisted/Bent (2981)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 10/08/2020

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 immediately post implant of this 29mm bioprosthetic aortic valve, a pressure of 60mmhg resulted in strong bleeding, which was stopped with a suture and pledgets.A second area of bleeding was observed near the polyester cloth which could not be stopped.The valve was ultimately explanted and replaced.During the explant procedure, the polyester ring ruptured.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the first instance of bleeding post implant came from the middle of the prosthesis.As previously reported, that area was repaired and the bleeding controlled.It was previously reported that during the explant process, the polyester ring on the prosthesis ruptured.Additional information was received that the rupture was a result of the explant process and "would not have happened if the prosthesis would still be implanted".That said, it was reported that the polyester ring and the tissue did not appear to be properly sewn and the tissue had a "lack" that overall caused the bleeding.Another valve of the same size and model was successfully implanted.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve appears to have been modified with the left coronary and right coronary buttons removed.Multiple pledgets remain attached to the aortic wall adjacent to the non-coronary cusp, which align with the reported event.A section of the sewing ring appears torn, adjacent to the non-coronary cusp and onto left/non-coronary inferior coaptive area.A section of the sewing cloth appears slightly everted.The myocardial tissue is torn approximately 1.9 cm in length, below from where the cloth sewing ring was torn.The tissue appears frayed with a sawtooth pattern to it.All commissures were intact.All leaflets were open, in a semi-relaxed position, flexible, and appeared intact.An intracuspal hematoma was observed in the non-coronary cusp below the torn sewing ring.Two perforations or punctures in the left cusp adjacent to the margin of attachment appear to be due to a sharp instrument such as forceps.An intracuspal hematoma appears to be associated to the puncture in the leaflet.There were no damages noted on the leaflets outside of the small perforations on the left cusp.The existing myocardium was inspected and was determined to be acceptable.No anomalies to the texture or color of the tissue were identified by the subject-matter experts.Sewing lines were inspected; there were no anomalies identified on the existing sewing cloth, surgeon suture line, or sew line.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.Based on the analysis of the returned valve, the valve was determined to be acceptable.The reported issues of the polyester ring and the tissue not appearing to be properly sewn and the tissue having a "lack" that caused the bleeding could not be confirmed.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: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 10708630
• MDR Text Key: 212255341
• Report Number: 2025587-2020-03177
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR995-29
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention