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

Model Number 995

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aneurysm (1708); Aortic Insufficiency (1715); Aortic Valve Stenosis (1717); Arrhythmia (1721); Calcium Deposits/Calcification (1758); Infarction, Cerebral (1771); Congestive Heart Failure (1783); Death (1802); Endocarditis (1834); Myocardial Infarction (1969); Rupture (2208); Sudden Cardiac Death (2510); Cusp Tear (2656)

Event Date 01/01/2009

Event Type  Death  

Event Description

Medtronic received information from an article in the journal of thoracic and cardiovascular surgery entitled ¿postimplantation morphologic changes of glutaraldehyde-fixed porcine aortic roots and risk of aneurysm and rupture.¿ this study evaluated the clinical outcomes and the risk of dilation and rupture of porcine aortic roots after implantation.Of a total of 308 patients, the freestyle bioprosthesis was used in 251 patients with a mean age of 62 years old.Patients who received the medtronic freestyle bioprosthesis had an echocardiogram before discharge from the hospital and were followed by the referring cardiologists, who obtained an echocardiogram to assess valve and ventricular function.One hundred fifty-eight patients with the freestyle bioprosthesis had a late study in the institution to measure the diameter of the porcine root.The mean duration of clinical follow-up was 5 years.There were ten operative deaths.One out of the ten had an aortic root rupture, was repaired, recovered and subsequently expired nine months post implant/repair of pneumonia with an intact porcine aortic root.There were 39 late deaths: 6 valve-related deaths (3 strokes, 2 prosthetic valve endocarditis [pve], and 1 structural valve deterioration [svd]), 7 cardiac-related deaths (3 sudden deaths, 1 myocardial infarction, and 3 congestive heart failure), and 26 deaths of other causes.All 3 patients who died suddenly were elderly with known coronary artery disease, and the death was believed to be due to dysrhythmias, myocardial infarction, or both.Twelve patients required reoperation: 2 for pve, 1 for detachment of the right coronary artery implantation, and 9 for svd.Of the patients with svd: one patient had aneurysm of the porcine aortic root of 50 mm in diameter with severe aortic insufficiency (ai) without cusp tears five years after implantation; one patient had aneurysm of 48 mm in diameter with severe ai caused by a cusp tear nine years after the operation; six patient had severe ai caused by cusp tear without significant dilation of the root, ranging from three to nine years after implantation; and one patient had aortic stenosis caused by severe calcification at nine years.Six patients had pve: two underwent reoperations (one died), and four were treated with antibiotics alone (one died during treatment, one died suddenly four months after successful medical therapy, and two were alive at the last follow-up).In the two patients who had surgical intervention for pve, the infection was noted to be limited to the cusps in one, and the other had an aortic root abscess.Seventeen patients had thromboembolic complications (six transient ischemic attacks and 11 strokes).Eight patients had severe ai, and one patient had mild-to moderate ai.All eight patients with severe ai underwent reoperation.It was not noted as to what patients were affected by which adverse effects nor was it mentioned which device these cases had.No other adverse patient effects were reported.

Manufacturer Narrative

Based on the content of the article, there was no information as to which devices were associated with the adverse events and no suggested malfunction of the devices.A device history records review could not be performed as the serial numbers were not provided.Based on the limited information received, a root cause of the adverse events could not be determined.

Manufacturer Narrative

Attempts to obtain additional information regarding the patients and devices in this study were unsuccessful.The date of death listed above is an estimate based on the date of publication of this article.The products have not been returned for analysis.Without return of the products, no definitive conclusions could be drawn regarding the clinical observations.Citation: david, t., armstrong, s., maganti, m., butany, j., feindel, c., bos, j., postimplantation morphologic changes of glutarald ehyde-fixed porcine aortic roots and risk of aneurysm and rupture.J thorac cardiovasc surg 2009; 137:94-100.(b)(4).

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): HEART VALVES SANTA ANA; 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: 4240795
• MDR Text Key: 5078248
• Report Number: 2025587-2014-00865
• 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: Foreign,Study,Literature,Company Representative,company represent
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• 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?: No
• Date Manufacturer Received: 11/24/2014
• 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): Death; Life Threatening; Required Intervention