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

Catalog Number	1125350-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.It should be noted that the xience alpine everolimus eluting coronary stent system, instructions for use, states: note the product use by (expiration) date specified on the product label.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 determined the device expiration issue appears to be related to the use error.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in a saphenous vein graft to the obtuse marginal.After implanting the xience alpine stent, it was noted to be expired.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: the date was filed incorrectly on the initial medwatch report as 04/09/2048, but should have been 04/09/2018.

• Brand Name: XIENCE ALPINE 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: 7466204
• Report Number: 2024168-2018-03112
• Device Sequence Number: 16175138
• Product Code: NIQ
• UDI-Device Identifier: 08717648199509
• UDI-Public: 08717648199509
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 03/17/2018
• Device Catalogue Number: 1125350-08
• Device Lot Number: 5031041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2048
• Supplement Date Received by Manufacturer: 04/09/2048
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR