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

Catalog Number	1125350-33
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
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 the failure to advance, difficulty removing the device, and stent dislodgement to be related to interactions with the patient anatomy.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 patient underwent a stenting procedure to treat a target lesion in the heavily calcified and tortuous proximal left anterior descending (lad) artery.The 3.5 x 38 mm xience alpine stent delivery system was advanced; however, due to the patient anatomy, the device was unable to cross.The stent delivery system was removed without difficulty.The 3.5 x 33 mm xience alpine stent delivery system was advanced; however, due to the patient anatomy, the device was unable to cross.Difficulty was noted during withdrawal and the stent dislodged.A snare device was advanced and the dislodged stent was pulled into the radial artery.The stent remained in the radial artery and the patient was sent for a surgical removal of the stent.The surgical procedure was performed and the stent was removed.Additionally, a coronary artery bypass graft procedure was performed to treat the target lesion in the lad.Post procedure, the patient is in stable condition.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: 6532120
• Report Number: 2024168-2017-03788
• Device Sequence Number: 324017
• Product Code: NIQ
• UDI-Device Identifier: 08717648199561
• UDI-Public: (01)08717648199561(17)190330(10)6032341
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 04/28/2017

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: 03/30/2019
• Device Catalogue Number: 1125350-33
• Device Lot Number: 6032341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 04/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention