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

Model Number 995

Device Problems Structural Problem (2506); Incomplete Coaptation (2507); Torn Material (3024)

Patient Problems Calcium Deposits/Calcification (1758); Stroke/CVA (1770); Endocarditis (1834); Eye Injury (1845); Ischemia (1942); Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Thromboembolism (2654)

Event Date 02/26/2014

Event Type  Injury  

Event Description

Medtronic received information from a medical journal article examining long-term outcomes for 500 patients from a single center over a 13-year period that there were 18 cases of structural valve deterioration associated with different sizes of this aortic root bioprosthesis.Of the 18 cases of identified structural valve dysfunction, re-intervention was performed for 10 patients.The article indicated that pathologic assessment of explanted devices showed leaflet calcification and a tear in 60% of the patients, leaflet tear in 20% of the patients, and predominant calcification of the device leaflets and commissures in 20% of the patients.However, the article did not specify if that assessment was performed only for the devices from the re-interventions or if the percentages also included any devices for which a dysfunction may have been observed via methods other than explant.In addition, the article noted that there were 14 cases of bioprosthesis valve endocarditis, (including four fatal cases), 25 cases of peripheral thromboembolism (including stroke in 17 cases, transient ischemic attack in five cases, mesenteric ischemia in one case, and acute central retinal artery occlusion in two cases, with persistent neurologic disabilities experienced by seven of the patients), and 28 cases of hemorrhages (including 14 fatal cases).The patient study population included 488 patients for whom follow-up was achieved for post-implant time periods ranging from one to 155 months, with a median of 105 months.The average demographics of the larger cohort of 500 patients were 75 years of age and 52% male.

Manufacturer Narrative

Additional information has been requested from the article's author contact.Without device-identifying information, medtronic¿s database could not be searched to determine if any of these events were previously reported.This is the second of two reports regarding this journal article.A separate report has been filed for deaths listed in the article.(b)(4).¿long-term results of freestyle stentless bioprosthesis in the aortic position: a single-center prospective cohort of 500 patients¿ authors: nicolas amabile, md, phd, olivier m.Bical, md, alexandre azmoun, md, ramzi ramadan, md, remi nottin, md, and philippe h.Deleuze, md the journal of thoracic and cardiovascular surgery http://dx.Doi.Org/10.1016/j.Jtcvs.2014.02.063.

Manufacturer Narrative

Subsequently, the article¿s author contact reported that the statistical analysis was performed after the patient data had been anonymized, and that it would not be possible to retrospectively align the patient outcomes and device issues discussed in the article with individual devices or patients.

Manufacturer Narrative

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

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: 4108332
• MDR Text Key: 4697454
• Report Number: 2025587-2014-00686
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 10/28/2014
• 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 Age: 00075 YR