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

Catalog Number	1125250-28
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/14/2018
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.The device was not returned for analysis.However, factors that could contribute to difficulty to remove (dispenser coil/sheath) include but are not limited to, manufacturing damage, damaged during shipping, and product damage during handling by user.Design and manufacturing controls have been established to mitigate possible causes.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 difficulty to remove (hoop) and difficulty to remove (sheath).The reported material deformation appears to be related to operational context of the procedure as it is likely the stent interacted with the sheath during removal causing the reported material deformation (flared stent).There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on removal of a 2.50x28mm xience alpine stent delivery system (sds) from the dispenser coil, resistance was felt.Additional resistance was also felt on removal of the protective sheath of the sds and the stent struts were noted to be flared.The device was not used.There was no patient involvement.The procedure was successfully completed with an additional xience alpine sds.There was no clinically significant delay in the procedure.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: 7696721
• Report Number: 2024168-2018-05546
• Device Sequence Number: 13665126
• Product Code: NIQ
• UDI-Device Identifier: 08717648199196
• UDI-Public: 08717648199196
• 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,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2018

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: 11/07/2020
• Device Catalogue Number: 1125250-28
• Device Lot Number: 7103141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1