MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ SUPRA VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number ESP200-19

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 19mm epic plus supra valve was selected for an implant.During the procedure, while implanting the valve, the sutures came out from one side of the holder.The surgeon eventually managed to implant the same valve with no consequence to the patient.The patient remained hemodynamically stable throughout the procedure.The patient was reported to be in stable condition.

Manufacturer Narrative

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

Manufacturer Narrative

An event of sutures came out from one side of the holder was reported.Information from field indicated that the event occurred while implanting the valve.One video was received from the field, appearing to be taken during implantation when the reported incident was observed.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the root cause of the reported incident could not be conclusively determined but is consistent with the valve coming into contact with a sharp object during implantation.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

N/a.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16305278
• MDR Text Key: 308878970
• Report Number: 2135147-2023-00402
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067033116
• UDI-Public: 05415067033116
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESP200-19
• Device Catalogue Number: ESP200-19
• Device Lot Number: 180720012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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