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

Catalog Number	1125325-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2018
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 products: guide wire: route, rinato.Guide catheter: corsair.Evaluation summary: the device was returned for analysis.The reported material deformation and difficulty to remove (guide wire) was confirmed.The reported device damaged by another device (guide wire and guiding catheter) could not be replicated in a testing environment as it was based on circumstances of the procedure.Additionally, the reported difficulty to remove (guiding catheter) was unable to be tested due to the device condition.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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to remove the guide wire.However, the additional 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 moderately calcified, eccentric de novo lesion in the proximal left anterior descending (lad) coronary artery that was 99% stenosed.An unspecified guide wire (gw) was advanced to the first diagonal artery.Then a 3.25 x 18mm xience alpine was deployed at the proximal lad.After the stent was deployed, the gw was attempted to be removed, but failed.Another attempt was made to remove the gw, with a non-abbott catheter, when strong resistance was met and it was noted that the stent got deformed.The gw was able to be simply removed together with the non-abbott catheter; however, the xience alpine stent was caught on the gw and catheter and was explanted.Another xience alpine was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.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: 7403856
• Report Number: 2024168-2018-02535
• Device Sequence Number: 13598501
• Product Code: NIQ
• UDI-Device Identifier: 08717648199448
• UDI-Public: 08717648199448
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2018

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: 10/30/2020
• Device Catalogue Number: 1125325-18
• Device Lot Number: 7101061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1