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	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical product: guide catheter extension: 6f guidzilla.Rhv: tuohy borst.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was confirmed.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the heavily tortuous, heavily calcified, and 95% stenosed artery causing the reported failure to advance.Additionally, after the device was removed the stent dislodged due to inadvertent handling.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 heavily tortuous, heavily calcified, 95% stenosed, mid circumflex coronary artery.A 2.50 x 38 mm xience alpine stent delivery system (sds) was advanced toward the lesion, met resistance with the anatomy and would not cross.Upon removal of the sds from the anatomy, the physician observed that the stent was still on the balloon and he did not see any sign of the stent being unstable.After the scrub tech received the sds, it was observed that the stent was not on the balloon.The stent was found on the sterile field and was observed to be undamaged.The scrub tech speculated that they may have inadvertently pulled the stent off the balloon while handling the sds after removal from the anatomy.The procedure was successfully completed with the implantation of two 2.50 x 18 mm xience alpine stents.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information 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: 7287673
• Report Number: 2024168-2018-01298
• Device Sequence Number: 10986505
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: 08717648199219
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/21/2018

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: 09/05/2020
• Device Catalogue Number: 1125250-38
• Device Lot Number: 7082541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 83