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

Catalog Number	1550225-18
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported expiration date error as the device was not returned for analysis.It should be noted that 41 units from this lot were re-worked to extend the shelf life of the device; however, this account did not receive any of the re-worked units.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that when opening the packaging for a 2.25x18mm xience sierra stent delivery system on the sterile table, it was inspected and noted that the device was expired on 10/7/2019.However, the pouch indicated a different date.The device was not used and there was no patient involvement.The chipboard box was discarded.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9304507
• Report Number: 2024168-2019-13407
• Device Sequence Number: 2030606
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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 Expiration Date: 10/07/2019
• Device Catalogue Number: 1550225-18
• Device Lot Number: 8092741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1