MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550300-15
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the radio frequency identification (rfid) consignment tracking tag for the xience sierra stent delivery system (sds) is showing the wrong expiration year, the month and date are correct.The expiration date on the rfid tag is showing 12/22/2008.There was no device use or patient involvement.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Date of event is estimated the device was not returned for analysis.A review of the electronic lot history record (elhr) and a lot level similar incident review for this product was not performed because the lot number was not reported and the product was not returned for analysis.The investigation determined the reported difficulties appear to be related to the format of the accounts barcode scanning setup as the account confirmed that their expiration date layout is set up differently than abbott vascular as they use dd/mm/yyyy format and abbott vascular barcode dates are set up yy/mm/dd.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience sierra device is being filed under a separate medwatch report number.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P031); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13894341
• Report Number: 2024168-2022-03122
• Device Sequence Number: 1790046
• Product Code: NIQ
• UDI-Device Identifier: 08717648227257
• UDI-Public: 08717648227257
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1550300-15
• Device Catalogue Number: 1550300-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown