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

Catalog Number	1125250-15
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 did not indicate a lot specific quality issue.The xience alpine everolimus eluting coronary stent system instructions for use (ifu) states that an unexpanded stent may be retracted into the guiding catheter one time only and should not be reintroduced into the artery once it has been pulled back into the guiding catheter, as the stent may be damaged when retracting it back into the guiding catheter.As the device was removed and readvanced (against the ifu), interaction with the anatomy and/or the previously implanted stent resulted again in the reported failure to advance and ultimately resulted in the reported stent dislodgement.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error and there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a procedure of the narrow, mildly calcified, distal right coronary artery (rca), after pre-dilatation, the xience alpine stent delivery system (sds) was advanced in a guideliner, through a previously implanted stent, but could not cross the lesion.The sds was removed and additional pre-dilatation was performed.Other devices were attempted, but could not cross the lesion.The same xience alpine sds was advanced again, past the previous stent, but still could not cross the lesion.The sds was removed, but the stent implant dislodged from the balloon in the proximal rca.Several attempts to retrieve the stent using a snare were unsuccessful and eventually the stent was deployed in the radial artery.There was no reported adverse patient sequela or a 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: 6822768
• Report Number: 2024168-2017-06978
• Device Sequence Number: 1523115
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: 08717648199165
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2017

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: 05/17/2020
• Device Catalogue Number: 1125250-15
• Device Lot Number: 7050941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 08/25/2017
• 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