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

Catalog Number	1125350-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported material deformation and the reported difficulty to position and difficulty to remove were able to be confirmed.The reported failure to advance the device was unable to 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 did not indicate a lot specific quality issue.The xience alpine everolimus eluting coronary stent system instructions for use states: 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.Subsequent movement in and out through the distal end of the guiding catheter may result in stent damaged when retracting the undeployed stent back into the guiding catheter.The investigation determined the reported difficulties appear to be related to circumstances of the procedure 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 the patient underwent a coronary procedure to treat a target lesion in the distal right coronary artery.The 3.5 x 38 mm xience alpine stent delivery system (sds) was advanced to the target lesion; however, the device was unable to cross.The sds was removed and a guide catheter extension was used to provide support.The xience alpine was re-advanced; however, there was resistance noted between the xience alpine and the guide catheter extension.The sds was able to exit the distal end of the guide catheter extension, but was still unable to cross the target lesion.During attempts to pull the sds back into the guide catheter extension, the sds became stuck.The proximal stent struts were flared.No additional attempts were made to remove the sds from the guide catheter extension, and the guide catheter extension was removed separately.The xience alpine sds was then removed with the guiding catheter as a single unit.An unspecified stent delivery system was then used, with the same guide wire, guide catheter and guide catheter extension, without issue.There was no reported adverse patient sequela or a clinically significant delay in 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: 6819477
• Report Number: 2024168-2017-06946
• Device Sequence Number: 59743
• Product Code: NIQ
• UDI-Device Identifier: 08717648199578
• UDI-Public: 08717648199578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2019
• Device Catalogue Number: 1125350-38
• Device Lot Number: 6100541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1