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

Model Number E100-29M

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

An event of a piece of the valve holder breaking and traveling to the patient's leg was reported.The results of the investigation are inconclusive since the device was not returned for analysis, however four photos were received for analysis.Based solely on the aforementioned photos from the field, the plug portion of the valve holder appeared to have become dislodged from the valve holder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

In (b)(6) 2018, a 29mm epic valve was implanted.During implant, a piece of the valve holder detached and was not recognized by the implanting medical team or the implanting md.The patient recovered and was discharged without any problems.At an unknown point following discharge, while in another country, the patient developed symptoms and evaluation identified a foreign material in the patient's leg.Intervention was taken to retrieve the foreign material from the patient's leg and it is reported the piece was consistent the white plug portion of the snap fit valve holder.The valve remains implanted and the detached holder piece has no impact on valve functionality.Patient identifier, age, and weight are protected under local privacy laws, and therefore are not recorded.

• Brand Name: EPIC STENTED PORCINE HEART VALVE W/FLEXFIT SYSTEM
• 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 ; 6517565400
• MDR Report Key: 7325201
• MDR Text Key: 101950199
• Report Number: 3001883144-2018-00028
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/08/2018

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: 09/03/2021
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: 6145188
• Other Device ID Number: 05414734027533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2017
• 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