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

Catalog Number	1125250-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: rinato; neos route.The device was returned for analysis.Visual and functional inspections were performed on the returned device.The difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.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 other similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties removing the device.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 procedure was to treat a non-tortuous, non-calcified, concentric, de novo, 70% stenosed lesion in the proximal left anterior descending artery.After performing thrombus aspiration and advancing a basket guide wire, the xience alpine 2.50 x 38 mm was deployed at 10 atmospheres.The stent delivery system (sds) balloon was inflated twice at 10 atmospheres.An attempt was made to remove the sds from the deployed stent but the sds could not be removed.The sds was inflated again at 12 atmospheres and it was deflated but the sds could not be removed from the deployed stent.On angiography the sds balloon was confirmed to have been deflated; meaning no contrast media was confirmed to be present inside the balloon.The deployed stent was well apposed to the vessel wall.In an attempt to help remove the sds from the deployed stent, a guide wire was advanced through the deployed stent and then the sds was removed from the stent successfully.There were no adverse patient effects and 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: 6575774
• Report Number: 2024168-2017-04262
• Device Sequence Number: 627666
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: (01)08717648199219(17)200108(10)6122141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 01/08/2020
• Device Catalogue Number: 1125250-38
• Device Lot Number: 6122141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/18/2017
• 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