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

Catalog Number	1125225-08
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: stent: 3.0x25mm xience alpine; guide wire: bmw universal.The product was not returned to abbott vascular for analysis.A review of the lot history record and similar incident query for this product was not performed since the lot number was not reported and the product was not returned.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy.Additionally, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The bmw universal is being filed under separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified lesion in the 1st obtuse marginal (om) coronary artery and left circumflex artery (lcx).A 2.25x8mm xience alpine stent was implanted in the 1st om; however, a portion of the stent struts were noted to be in the lcx artery and were not fully expanded.Post dilatation was performed to fully appose the stent to the vessel wall.A 3.0x25mm xience alpine stent was implanted in the lcx.A ht-bmw universal guide wire was advanced; however, resistance was met with the stent struts of the 2.25x8 mm xience alpine stent.The guide wire was pulled back to re-position and was noted to have got caught on the stent struts of the 2.25x8 mm xience alpine stent.The ht bmw universal guide wire started to unravel during removal from the patient anatomy and the unraveled portion was noted to have separated in the patient anatomy.A snare device was used to retrieve the majority of the separated portion; however, the tip was unable to be retrieved.There was no damage noted to the 2.25x8 mm xience alpine stent.A 3.25x23mm xience alpine stent was implanted in the om to embed the separated tip and treat the target lesion to complete the procedure successfully.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: 7791058
• Report Number: 2024168-2018-06311
• Device Sequence Number: 13832391
• Product Code: NIQ
• UDI-Device Identifier: 08717648199059
• UDI-Public: 08717648199059
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2018

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 Catalogue Number: 1125225-08
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/16/2018
• 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: 63 YR