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

Catalog Number	1125325-15
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	09/07/2016
Type of Reportable Event	Serious Injury
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 did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and the reported shaft kink appear to be related to circumstances of the procedure.It should be noted that dissection is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a chronic total occluded lesion in the mid right coronary artery.During advancement of the 3.25x18 mm xience alpine stent delivery system (sds) resistance was felt with the patient anatomy, force was used and the shaft kinked.The sds was removed.A 3.25x15 mm xience alpine sds was advanced and the same issue occurred, however this time a dissection occurred.The 3.25x15 mm xience alpine sds was removed.A 3.0x15 mm xience alpine was used to treat the dissection and a 3.0x12 mm non-abbott sds was used to complete the procedure.There was no adverse patient sequel and no 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: 5959190
• Report Number: 2024168-2016-06143
• Device Sequence Number: 18851611
• Product Code: NIQ
• UDI-Device Identifier: 08717648199431
• UDI-Public: (01)08717648199431(17)190531(10)6052641
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/15/2016

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: 05/31/2019
• Device Catalogue Number: 1125325-15
• Device Lot Number: 6052641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 09/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention