MAUDE Adverse Event Report: ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA) EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-25

Device Problems Patient-Device Incompatibility (2682); Device Contamination with Chemical or Other Material (2944); Naturally Worn (2988); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 08/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This epic supra ( esp100-25 [sn: (b)(4)]) implanted on (b)(6) 2013 at (b)(6) hospital was explanted on (b)(6) 2015 by the original implanting surgeon.Valve integrity of the explanted device appeared consistent and there were no leaflet tears or immediate signs of wear or svd visually noted.The leaflets were covered with an unidentified organic material which had attached to the each leaflet cusp on both superior and inferior sides of the valve.Part of the polyester sewing cuff was torn during the explantation of the valve and exposed the silicone ring.A photograph and video were taken of the explanted valve.Anesthesiologist advised that the eao of the valve prior to explant was 0.5cm2/m2.The patient had elected to have a mechanical valve as a replacement device and the onyx aortic valve was selected.A 25mm onyx valve was implanted and the aorta closed.However, the onyx valve was removed prior to the patient coming off by-pass as it appeared to be an unsuitable fit for the patient's anatomy.The surgeon then elected to implant a 23 aehpj (sn: (b)(4)).The aorta was then closed and came off by-pass.

Manufacturer Narrative

The results of this investigation indicated there was fibrous thickening of cusp 1.There was organizing thrombus with focal calcification on the outflow surface of cusps 1 and 3.There was a thin layer of fibrin on cusps 1 and 2.Multiple perforations were observed in cusp 2.There was fibrous pannus ingrowth on the inflow surface of cusp 3.Special stains were negative for organisms, and no acute inflammation was present.There was no evidence found to suggest the cause of the fibrin, thrombus, calcification, pannus, and perforations were due to an intrinsic defect in the valve, as supported by review of the valve's device history record and the analysis performed.The cause of the reported event remains unknown.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer (Section G): ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA); caixa postal 106; belo horizonte 34000 -000; BR 34000-000
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5086964
• MDR Text Key: 26153704
• Report Number: 3001743903-2015-00035
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/11/2014
• Device Model Number: ESP100-25
• Device Catalogue Number: ESP100-25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2010
• 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: 70 YR
• Patient Weight: 93