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	05/08/2018
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.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter during advancement causing the reported difficulty to position and subsequent material deformation (stent flare).The device was removed and interacted with the guiding catheter during retraction causing the reported difficulty to remove.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous, mildly calcified, 75% stenosed concentric lesion in the mid left anterior descending (lad) coronary artery.Pre-dilatation was performed with a 2.5x15 mm non-abbott device.A 2.5x38 mm xience alpine stent delivery system (sds) was advanced; however, resistance was noted with a 6 fr non-abbott guiding catheter before passing the insertion site of the vessel.The sds was removed independently from the patient anatomy; however, resistance was felt with the guiding catheter.The proximal end stent struts were noted to be flared.A new same size xience alpine sds was advanced using the same non-abbott guiding catheter to successfully complete the procedure.There was no reported adverse patient effects or a clinically significant delay in the procedure.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: 7534907
• Report Number: 2024168-2018-03818
• Device Sequence Number: 13957893
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: 08717648199219
• 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,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: 08/07/2019
• Device Catalogue Number: 1125250-38
• Device Lot Number: 6072841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1