MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. TAILOR FLEXIBLE ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number	TARP-31
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 31mm tailor flexible annuloplasty ring was implanted following the expiration date.The product was reported to have expired on 07/01/2019.Per the site, (b)(6) agent did not retrieve the expired stock from the hospital.Additional information has been requested.
Event or Problem Description
On (b)(6) 2019, a 31mm tailor flexible annuloplasty ring was implanted following the expiration date.No patient consequences were reported.The product was reported to have expired on 01 july 2019.Per the site, the vektör agent did not retrieve the expired stock from the hospital.
Additional Manufacturer Narrative
Additional information: b5 (event), g4 (pma/510k), h2 (if follow-up, what type), h6, h10.An event of use of expired product was reported.The results of the investigation confirmed that the tailor flexible annuloplasty ring expired on 1 july 2019 which was prior to the reported event date on (b)(6) 2019.A review of abbott records indicated that the valve was invoiced to vektor prior to its expiration date.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including product sterilization prior to release and verification of the expiration date listed on the product label.The root cause of the reported event is consistent with user error, per the site the vector agent did not retrieve the expired stock from the hospital and the user did not check the expiration date prior to use.

• Brand Name: TAILOR FLEXIBLE ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8942186
• Report Number: 2648612-2019-00063
• Device Sequence Number: 16201568
• Product Code: KRH
• UDI-Device Identifier: 05414734007702
• UDI-Public: 05414734007702
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K014161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: TARP-31
• Device Catalogue Number: TARP-31
• Device Lot Number: 4681108
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other