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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE
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MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE Back to Search Results
Model Number FR995-25
Device Problems Material Rupture (1546); Insufficient Information (3190)
Patient Problem Hemostasis (1895)
Event Date 06/13/2019
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 bioprosthetic valve, a rupture of the dacron occurred above the green suture line resulting in bleeding.The valve was explanted and replaced with another valve.No additional adverse patient effects were reported. .
 
Manufacturer Narrative
Conclusion: a review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.The explanted valve was not returned for analysis, therefore a conclusive cause of the bleeding could not be determined.The surgeon reported an assumption that the rupture was related to valves with a darker beige the aortic root and not to brighter beige colored valves, however this could not be confirmed based on the available information.There have been no trends of complaints for this type of event.During manufacturing, there are multiple downstream checkpoints prior or after the valve assembly process to ensure the tissue quality for each freestyle valve.Each freestyle tissue undergoes ¿selection / evaluation¿ process prior to transfer to valve assembly area.The ¿selection / evaluation¿ process includes 100% inspection on tissue characteristics.Each freestyle valve undergoes a 100% final inspection on tissue characteristics that may contribute to tearing, i.E.Scarring, unsecured flaps of tissue, large fenestration with thin / weak tissue surrounding, punctured / abraded tissue, crease / stress fold, etc.It was reported that the bleeding was under the green suture line, bleeding as if through as a sieve and no rupture was seen.This could not be confirmed as the explanted valve was not returned for analysis.It was reported that six weeks after replacing this valve with a valve of the same model and size, the patient died.The cause of death was from multiple co-morbidities.There was no evidence to suggest that the valve or its function contributed to the patient¿s death.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during the implant of this bioprosthetic valve, a rupture of the dacron occurred above the green suture line resulting in bleeding.The valve was explanted and replaced with another valve.The surgeon reported an assumption that the rupture was related to valves with a darker beige the aortic root and not to brighter beige colored valves.No additional adverse patient effects were reported.  medtronic received additional information that the bleeding was under the green suture line, bleeding as if through as a sieve and no rupture was seen.The valve was replaced with the same model and size valve.Six weeks following the implant of the valve, the patient died.The cause of death was from multiple co-morbidities.There was no evidence to suggest that the valve or its function contributed to the patient¿s death.
 
Manufacturer Narrative
Medtronic received additional information that the bleeding was under the green suture line, bleeding as if through as a sieve and no rupture was seen.The valve was replaced with the same model and size valve.H.6.Device code 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.
 
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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 Key8826436
MDR Text Key152191523
Report Number2025587-2019-02335
Device Sequence Number1
Product Code LWR
Combination Product (y/n)N
PMA/PMN Number
P970031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/30/2023
Device Model NumberFR995-25
Device Catalogue NumberFR995-25
Was Device Available for Evaluation? No
Date Manufacturer Received10/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
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