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

Catalog Number	1125400-08
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
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 products: guide wire: runthrough ns hc.Guide catheter: hyperion.Evaluation summary: the device was 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 did not indicate a lot specific quality issue.The reported material deformation, device damaged by another and stent dislodgement 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.The reported difficult to remove was unable to be replicated in a testing environment due to the condition of the returned device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 located in the left main coronary artery that was mildly tortuous, heavily calcified and 90% stenosed.After pre-dilating the lesion with a non-abbott balloon catheter, the xience alpine (xa) 4.0 x 8 mm stent delivery system (sds) was advanced, however, got stuck with a previously deployed stent in the proximal left anterior descending coronary artery.When the xience alpine was being pulled back, the stent implant dislodged.An additional guide wire was advanced in the lesion using the buddy wire technique, and a non-abbott balloon catheter was advanced distally and inflated to withdraw the xa stent, however the stent became deformed and could not be removed.A snare device was advanced over the second guide wire, however the snare got caught with the first guide wire inside the dislodged stent.Finally, a snare device was able to snare the dislodged stent and successfully retrieve it into the sheath that was at the puncture site.The procedure was completed with a 4.0 x 12 mm xience alpine stent being deployed.There were no adverse patient effects reported.Additional time was required to retrieve the dislodged stent however it did not cause any serious impact to the patient.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: 6597840
• Report Number: 2024168-2017-04579
• Device Sequence Number: 78799
• Product Code: NIQ
• UDI-Device Identifier: 08717648199592
• UDI-Public: (01)08717648199592(17)190712(10)6070741
• 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): 05/30/2017

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: 07/12/2019
• Device Catalogue Number: 1125400-08
• Device Lot Number: 6070741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 05/30/2017
• 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