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

Catalog Number	1125275-15
Health Effect - Clinical Code	Embolism (1829)
Date of Event	07/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant devices: stent: 2.75x15mm xience alpine, guide catheter extension code (b)(4): distal to stent.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effect of embolism is listed in the xience alpine, everolimus eluting coronary stent system instructions for use (ifu) as a known patient effect of coronary stenting procedures.Additionally, the ifu states: place the stent in the distal lesion before the proximal lesion in order to minimize dislodgement risk incurred by traversing through deployed stents.The investigation determined that the reported failure to advance and subsequent treatment appear to be related to circumstances of the procedure; however, the reported stent dislodgement and difficult to remove appears to be related to the use error.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and 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 coronary procedure to treat a target lesion in the heavily calcified and tortuous circumflex artery.Pre-dilatation was performed.A 2.75 x 15 mm xience alpine stent delivery system was advanced into the patient anatomy, but was unable to cross to the distal lesion and was implanted in the proximal lesion instead.Additional dilatation was performed and a 2.5 x 15 mm xience alpine stent was implanted in the distal lesion.The mid lesion was still untreated; therefore, additional dilatation was performed and the physician advanced a second 2.75 x 15 mm xience alpine to the target site.The device was unable to cross and the stent edge caught on the edge of the implanted 2.75 x 15 mm stent.The device was removed and some resistance was felt.Upon removal, it was noted that the stent was not on the delivery system, and was not in the guide catheter.Angiography noted that the dislodged stent was in the mid lesion, between the two implanted stents, at the location the physician had intended to deploy it.A guide wire was advanced through the dislodged stent, and a 2.5 x 15 mm dilatation catheter was advanced through the stent.The physician was able to inflate the dilatation catheter balloon, deploying the stent at the intended location.There was no adverse patient sequelae and no clinically significant delay.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: 6757552
• Report Number: 2024168-2017-06302
• Device Sequence Number: 1490588
• Product Code: NIQ
• UDI-Device Identifier: 08717648199257
• UDI-Public: 08717648199257
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/01/2017

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 Catalogue Number: 1125275-15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/01/2017
• 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