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

Catalog Number	1125350-12
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/08/2018
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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (stent migration during deployment) with patient effect of foreign body in patient.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 3.5x8mm xience alpine is being filed under a separate manufacturing report number.
Event or Problem Description
It was reported that the procedure was to treat a 99% stenosed and heavily calcified lesion in the ostium artery.Following pre-dilatation, a 3.5x12mm xience alpine stent was being deployed; however, the stent migrated forward during deployment and was deployed outside of the target lesion.A 3.5x8mm xience alpine stent delivery system (sds) was being advanced to be placed proximal to the 3.5x12mm xience alpine stent; however, the sds was advanced further than needed and when attempting to pull back the stent to the target lesion the stent got stuck on the struts of the previously deployed stent and the 3.5x8mm xience alpine stent dislodged.An attempt to retrieve the stent with an additional guide wire utilizing a guide liner for support was made but failed.An unknown 1.5mm balloon catheter was used to slightly expand the stent so that an unknown 3.5mm balloon catheter could be used to successfully deploy the stent inside the previously implanted 3.5x12mm xience alpine stent.The procedure was successfully completed with a new 3.5x8mm xience alpine deployed at the target lesion.There was no 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: 7398060
• Report Number: 2024168-2018-02481
• Device Sequence Number: 1325494
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: 08717648199516
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 01/08/2021
• Device Catalogue Number: 1125350-12
• Device Lot Number: 7121961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/04/2018
• 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: Other
• Patient Age: 74 YR