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

Catalog Number	1125300-12
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
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.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 an interaction with the clips of the saphenous vein graft (svg) contributed to the resistance during advancement and the stent becoming disrupted on the balloon such that it subsequently dislodged.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 3.0x12 xience alpine stent delivery system (sds) met resistance during advancement to the saphenous vein graft (svg) for the right coronary artery.The resistance was felt near one of the clips on the svg.The sds reached the target lesion and was ready to be deployed, but a stent was not on the sds.The sds was removed from the anatomy.The missing stent was unable to be located.The back table and the patient were checked, but the stent could not be found.Another xience alpine stent was used to complete the procedure successfully.There were no adverse patient effects and no clinically significant delay in the procedure.The patient is doing fine.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: 6216552
• Report Number: 2024168-2016-09406
• Device Sequence Number: 16421667
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: (01)08717648199332(17)190919(10)6090941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2019
• Device Catalogue Number: 1125300-12
• Device Lot Number: 6090941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 12/30/2016
• 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: GRAFT CLIPS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 101