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

Catalog Number	1125225-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2018
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.(b)(4).Evaluation summary: a visual inspection was performed on the returned device.The reported stent dislodgement was confirmed; however the reported failure to advance 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.An unexpanded stent 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 should not be performed, as the stent may be 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 as it is likely the device interacted with the moderately calcified and 80-85% stenosed artery resulting in the reported failure to advance.Additionally, multiple attempts were made to cross the lesion and manipulation of the device and/or interaction with other devices as the device was removed then re-advanced (against the instructions for use) resulted in the noted stent dislodgement.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 procedure was to treat a lesion in the non-tortuous, moderately calcified, 80 - 85% stenosed, mid left anterior descending (lad) coronary artery.A 2.25 x 12 mm xience alpine stent delivery system (sds) was advanced to the lesion, met resistance with the calcium and would not cross the lesion.About a dozen unsuccessful attempts were made to cross the lesion and during several of those attempts, the sds was pulled back into the guide catheter.During removal of the sds from the anatomy, the stent dislodged and a snare was used to retrieve the stent from the anatomy.A non-abbott balloon catheter was used to successfully complete the procedure.There was no reported 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: 7248410
• Report Number: 2024168-2018-00885
• Device Sequence Number: 1017401
• Product Code: NIQ
• UDI-Device Identifier: 08717648199066
• UDI-Public: 08717648199066
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: 09/14/2020
• Device Catalogue Number: 1125225-12
• Device Lot Number: 7090741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2018
• Initial Report FDA Received Date: 02/07/2018
• 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: 75 YR