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

Catalog Number	1125250-12
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not 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 identified no other similar incidents reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during retraction of the sds back to the tip of the guiding catheter, interaction with the guiding catheter, as the guiding catheter was not coaxially aligned, resulted in the reported difficulty to remove.Interaction with the guiding catheter and/or manipulation of the device resulted in the reported material deformation (flared struts).There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the proximal left anterior descending artery.After placing the 2.5 x 12 mm xience alpine stent delivery system (sds) into the patient it was determined on angiography that the stent was too short for the lesion.During retraction of the sds the catheter caught on the tip of the guide catheter.After retraction the stent implant was observed to have a flared stent strut.A new, longer stent was used to complete the procedure successfully.There was no adverse patient effects or clinically significant delay in the procedure reported due to the device issue.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: 6960090
• Report Number: 2024168-2017-08319
• Device Sequence Number: 10904392
• Product Code: NIQ
• UDI-Device Identifier: 08717648199158
• UDI-Public: 08717648199158
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/18/2017

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: 08/17/2020
• Device Catalogue Number: 1125250-12
• Device Lot Number: 7080361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 91