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

Model Number 995

Device Problems Perivalvular Leak (1457); Material Rupture (1546); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Endocarditis (1834); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 09/11/2012

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product analysis: the product has not been returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Title: long-term clinical and echocardiographic follow-up of the freestyle stentless aortic bioprosthesis citation: circulation (2012) 126[suppl 1]:s198¿ s204 (doi 10.1161/circulationaha.111.084806 ) authors: siamak mohammadi, md; vincent tchana-sato, md; dimitri kalavrouziotis, md, msc; pierre voisine, md; daniel doyle, md; richard baillot, md; sandro sponga, md; jacques metras, md; jean perron, md; francois dagenais, md date of publish was used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review regarding long term echocardiographic follow up after the implant of a freestyle aortic bioprosthetic valve.All data was collected from a single center between 1993 and 2011.The study population included 430 patients (predominantly female; mean age 68.2 +/- 8.2 years), all of which were implanted with this aortic bioprosthetic valve (serial numbers not provided).Among all patients fifteen in hospital deaths occurred, which included: 11 deaths due to low cardiac output, 1 death due to renal failure, 2 deaths due to multiorgan failure and 1 death due to intestinal ischemia.Five of the fifteen reported deaths occurred in patients who had a concomitant coronary artery bypass graft (cabg); however there was no indication that the valve caused the need for the cabg.None of the deaths were attributed to the device.Among all patients, adverse events included; 43 incidents of bleeding, 104 incidents of new onset atrial fibrillation, 18 incidents of cerebrovascular accident, 7 incidents of either pulmonary or wound infections, and delayed pleural or pericardial effusion.Fifty-one re-operations were reported which included: 4 incidents of re-operation due to patient prosthesis mismatch, 6 incidents of endocarditis and 14 incidents of re-operation due to non-structural valve deterioration.Additional adverse events included twenty-seven incidents of structural valve deterioration; 21 incidents of severe aortic insufficiency that were due to leaflet tear.Of these patients with aortic insufficiency; 21 incidents of aortic regurgitation and 6 incidents of aortic stenosis were also reported.Four re-operations occurred for the following reasons; one incident of increased gradient measurements (105 mm hg) attributed to patient prosthesis mismatch and three incidents of severe paravalvular leak (pvl) due to valve dehiscence.These adverse events were attributed to "technical issues" that occurred during the first year this valve was implanted at the facility.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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5746660
• MDR Text Key: 48092986
• Report Number: 2025587-2016-00927
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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: 06/13/2016
• Initial Date FDA Received: 06/23/2016
• Supplement Dates Manufacturer Received: 06/13/2016
• Supplement Dates FDA Received: 09/23/2017
• 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: 68 YR