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

Catalog Number	1125275-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
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).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.The reported difficulty to remove from the guiding catheter and difficulty removing from the introducer sheath could not be replicated in a testing environment due to the condition of the returned device.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 xience alpine everolimus eluting coronary stent system (eecss), domestic electronic 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.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 mildly tortuous, mildly calcified eccentric de novo lesion in the mid left anterior descending coronary artery that was 90% stenosed.A 2.5 x 12mm xience alpine stent was implanted at the lesion.A 2.75 x 18 xience alpine stent delivery system (sds) was then attempted to cross the lesion but was unable due to the anatomy.Another attempt was performed after it had been pre-dilatated twice but was unable to and it was then decided to be removed.During withdrawal of the xience alpine into the guiding catheter (gc), the proximal side of the stent became stuck at the tip of the gc.Then the guiding catheter and the xience alpine sds were attempted to be removed together.However, as it was being removed, the stent then got trapped at the distal tip of the sheath and had dislodged in the radial artery.A snare device was used to retrieve the stent.Since the snared stent was unable to be withdrawn into the sheath, both the stent and the sheath were removed.The procedure was discontinued leaving the lesion intact, and treatment would be decided later.The physician considered there was no causal relationship between the incident and the device.There was no adverse patient sequela reported.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: 7289934
• Report Number: 2024168-2018-01313
• Device Sequence Number: 14028728
• Product Code: NIQ
• UDI-Device Identifier: 08717648199264
• UDI-Public: 08717648199264
• 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): 02/22/2018

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: 05/04/2020
• Device Catalogue Number: 1125275-18
• Device Lot Number: 7041761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: SION BLUESTENT: XIENCE ALPINE 2.5X12
• Outcome Attributed to Adverse Event: Required Intervention