MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number SARP-32

Device Problem Expiration Date Error (2528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

An event of implantation of an expired product was reported.The 32 mm semi-rigid annuloplasty ring batch number 4783013 expired on august 27, 2018 which was prior to the reported event date of (b)(6) 2018.A review of distribution records confirmed that this product was distributed prior to its expiration date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including verification of the expiration date listed on the product label.The root cause of the reported event is consistent with user error.Additionally, per the instructions for use (ifu) "do not use the ring if the ¿use by¿ date on the packaging has passed.".

Event Description

On (b)(6) 2018, a 32 mm semi-rigid annuloplasty ring (sarp) was selected for a mitral repair after a quadrangular p2 resection.The sarp rings had been scattered on the back table searching for the correct size.The circulator handed the ring to the physician without verifying the expiration date.The physician sutured in the ring and as the procedure was being completed, an operating room staff member identified the device had an expiration date of (b)(6) 2018.The physician elected to leave the device implanted and closed the patient's chest.Post-operatively, the patient was reported to be stable.The patient was notified about the device expiration, and no additional precautions have been taken.The patient has since been discharged on antibiotics.

• Brand Name: SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7913075
• MDR Text Key: 121849748
• Report Number: 3007113487-2018-00023
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734007528
• UDI-Public: 05414734007528
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2018
• Device Model Number: SARP-32
• Device Catalogue Number: SARP-32
• Device Lot Number: 4783013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• 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): Other
• Patient Age: 57 YR
• Patient Weight: 96