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

Catalog Number	1125350-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2016
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.Actual weight (b)(6).Evaluation summary: visual and dimensional inspections were performed on the returned device.The stent dislodgement and stent damage were 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 of the reported lot did not indicate a lot specific quality issue.The investigation determined it is likely that inadvertent user mishandling during removal of the protective sheath contributed to the dislodgement and subsequent stent damage.Based on the information reviewed, 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 removal of the mandrel and sheath, the stent stretched and dislodged; however, it was not noticed until the stent delivery system was being back loaded on the guide wire.The device was not used.There was no adverse patient effect or a clinically significant delay in procedure reported.There was no additional information 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: 6201484
• Report Number: 2024168-2016-09218
• Device Sequence Number: 509583
• Product Code: NIQ
• UDI-Device Identifier: 08717648199578
• UDI-Public: (01)08717648199578(17)190927(10)6092141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2016

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: 09/27/2019
• Device Catalogue Number: 1125350-38
• Device Lot Number: 6092141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 67