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

Catalog Number	1125400-08
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2017
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.The device was returned for analysis.Visual inspections were performed.The loose (dislodged) stent was confirmed.The difficulties removing the protective sheath could not be replicated in a testing environment as the sheath and stent delivery system were not returned.The investigation was unable to determine a conclusive cause for the reported difficulties removing the protective sheath however the loose (dislodged) stent appears to be related to circumstances of the procedure.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.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 during preparation of the 4.0 x 8 mm xience alpine stent delivery system, the protective sheath and mandrel were difficult to remove; however, they were able to be removed.Upon removal of the sheath, the stent was noted to be loose.The physician touched the stent with a finger and the stent easily dislodged from the balloon.The device was not used and a 3.5 x 8 mm xience alpine was used instead.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• 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: 6505367
• Report Number: 2024168-2017-03402
• Device Sequence Number: 16460811
• Product Code: NIQ
• UDI-Device Identifier: 08717648199592
• UDI-Public: (01)08717648199592(17)180602(10)5052641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2017

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: 06/02/2018
• Device Catalogue Number: 1125400-08
• Device Lot Number: 5052641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1