MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP100-23

Device Problem Fracture (1260)

Patient Problem Aortic Insufficiency (1715)

Event Date 09/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Two photographs of the explanted 23 mm sjm epic supra bioprosthesis were received from the field.One photograph showed the inflow side of the valve, and the other photograph showed the outflow side of the valve.In the photographs, what appeared to be blood was observed on both the inflow and outflow surface of all three cusps, the pericardial strip, and the annular suture line.Areas of the sewing cuff appeared to be disrupted, and the cuff material contained what appeared to be blood and blue and white sutures.What appeared to be white tissue growth was observed on the outflow surface of all three cusps, from approximately the base to the mid-portion.Due to the limited view of the device no additional observations were able to be made.The device history record was reviewed, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported event remains unknown.

Event Description

On (b)(6) 2015, a patient was implanted with a 23 mm epic supra valve.During the (b)(6) 2016, an increased gradient was noted and the valve was explanted on (b)(6) 2016 and replaced with a 21 mm on-x mechanical valve.The status of the patient is unknown.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6016544
• MDR Text Key: 56931942
• Report Number: 3008452825-2016-00138
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Type of Report: Initial
• Report Date: 09/14/2016

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 Expiration Date: 07/14/2019
• Device Model Number: ESP100-23
• Device Catalogue Number: ESP100-23
• Device Lot Number: 5181679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR