MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC STENTED PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E100-33M-00

Device Problems Product Quality Problem (1506); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022, a 33mm epic valve was selected for procedure.It was noted that at an unknown point during the procedure the epic valve seemed to "fall apart." the patient status is unknown.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

N/a.

Manufacturer Narrative

An event of the valve ¿falling apart¿ was reported.Investigation of the device upon return to abbott found that the white spool had disconnected from the valve holder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization, which includes inspection of the holder and inspection of the final valve assembly.No potential handling issues during holder attachment, final inspection, final sterilization, and packaging were identified that could cause the spool to detach from the holder.The cause of the detached spool could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Medical device problem code: code 1506 (product quality problem) was removed.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15126315
• MDR Text Key: 304797495
• Report Number: 2135147-2022-00594
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: 05414734055611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E100-33M-00
• Device Catalogue Number: E100-33M-00
• Device Lot Number: BR00032662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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