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

Model Number 995

Device Problem Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Congestive Heart Failure (1783); Death (1802); Endocarditis (1834); Hemorrhage, Cerebral (1889); Hemostasis (1895); Ischemia (1942); Pneumonia (2011); Sepsis (2067); Pseudoaneurysm (2605)

Event Date 05/06/2015

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.(b)(4).Title of article: long term outcomes following freestyle stentless aortic bioprosthesis citation: heart, lung and circulation xx, 1-7, 2015, 10.1016/j.Hlc.2015.05.011 authors: andrew g sherrah, richmond w jeremy,phd, rajesh puranik, paul g bannon, p nicholashendel, matthew s bayfield, michael kwilson, pet the date of publish (b)(6) 2007 used for event date.

Event Description

Medtronic received information via literature review that a study was performed to evaluate freestyle stentless bioprosthesis (fsb) implantation for up to 10 years (serial numbers not provided).The fsb was implanted as a full aortic root replacement in 87.8% patients.The study population included 237 patients, predominantly male with a mean age of 63 years.Among all patients, thirty (30) deaths were reported, which included deaths from: cardiac failure, bleeding, cerebral vascular accident (cva), mesenteric ischemia, sepsis, pneumonia, hypoxic arrest, and unrelated terminal illness.There was no allegation against the valve or its function nor was there any allegation that the valve directly contributed to the patient's death.Among all patients, forty-nine (49) adverse events occurred, which included: hemostasis for intra-operative bleeding, cerebral vascular accident (cva), permanent pacemaker implantation, mild to severe aortic regurgitation (ar), pseudoaneurysm, endocarditis and paravalvular leak (pvl).No additional adverse patient effects were reported.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5332423
• MDR Text Key: 34591761
• Report Number: 2025587-2015-01413
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2015

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 Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: 12/11/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00063 YR