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

Catalog Number	1125225-15
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (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.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy causing the reported failure to advance and subsequent stent dislodgement.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 did not indicate a lot specific quality issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with heavy tortuosity and heavy calcification in the obtuse marginal coronary artery after the patient had refused to have coronary artery bypass (cabg) surgery.A 2.25 x 15 mm xience alpine stent delivery system (sds) was advanced in the vessel, but met resistance due to the circumflex having an acute angulation and being very tortuous.When the sds was withdrawn from the patient anatomy, it was noted the stent had dislodged in a calcium bed in the vessel.A snare device was used to retrieve the dislodged stent but was unsuccessful.A 3.5 x 15 mm xience alpine stent was deployed crushing the dislodged stent against the calcified artery wall.Therefore, the procedure was aborted as the patient had severe coronary artery disease and had refused cabg.The patient will continue with medical management.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: 7422555
• Report Number: 2024168-2018-02658
• Device Sequence Number: 39323
• Product Code: NIQ
• UDI-Device Identifier: 08717648199073
• UDI-Public: 08717648199073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/11/2018

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: 02/13/2021
• Device Catalogue Number: 1125225-15
• Device Lot Number: 8020641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/11/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 90