MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1074350-23
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The reported device expiration issue was confirmed.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 other similar incidents from this lot.It should be noted that the xience xpedition everolimus eluting coronary stent system instructions for use states: note the product use by date.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as the device was used past the expiration date.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that a 3.50 x 23 mm xience xpedition stent was successfully implanted on (b)(6) 2017.It was later determined that the expiration date for the xience xpedition was in (b)(6) 2017 and should not have been used in the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6490209
• Report Number: 2024168-2017-03127
• Device Sequence Number: 627835
• Product Code: NIQ
• UDI-Device Identifier: 08717648162558
• UDI-Public: (01)08717648162558(17)170121(10)5011641
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2017

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: 01/21/2017
• Device Catalogue Number: 1074350-23
• Device Lot Number: 5011641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: JR4
• Patient Age: 65 YR