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

Catalog Number	1125250-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2017
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 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 that as the sds was advanced, resistance was met with the heavily calcified, moderately tortuous and 99% stenosed anatomy resulting in the reported failure to advance.During removal interaction with the guiding catheter resulted in the reported material deformation (flared) thus resulting in the reported difficulty to remove.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 an eccentric, de novo lesion located in the heavily calcified, moderately tortuous, 99% stenosed left anterior descending coronary artery.After pre-dilatation was performed, a 2.5 x 18 mm xience alpine stent delivery system (sds) was advanced to the target lesion; however, it was unable to cross.During removal of the sds from the anatomy the stent implant caught on the tip of the guiding catheter which resulted in flared proximal stent struts.A new same size device was able to cross the target lesion with the use of a guideliner catheter.The procedure was completed after stenting.No adverse patient effects or clinically significant delay in the procedure were 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: 7202420
• Report Number: 2024168-2018-00448
• Device Sequence Number: 13633998
• Product Code: NIQ
• UDI-Device Identifier: 08717648199172
• UDI-Public: 08717648199172
• 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): 01/17/2018

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: 06/12/2020
• Device Catalogue Number: 1125250-18
• Device Lot Number: 7053161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1