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

Catalog Number	1125250-23
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The xience alpine everolimus eluting coronary stent system, instructions for use (ifu), states: although the safety and effectiveness of treating more than one lesion per coronary artery with xience alpine stents have not been established, if this is performed, place the stent in the distal lesion before the proximal lesion in order to minimize dislodgement risk incurred by traversing through deployed stents.In this case, it is likely the ifu deviation contributed to the reported difficulties.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 that the reported difficulties appear to be related to the use error.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 performed to treat a long lesion with fibrotic calcification in the left anterior descending (lad) coronary artery.A 2.5 x 38 mm xience alpine stent was deployed successfully in the mid-section of the lad.The 2.5 x 23 mm xience alpine stent delivery system (sds) was advanced for distal placement, but could not cross the 2.5 x 38 mm xience alpine stent implant.When the 2.5 x 23 mm xience alpine sds was pulled back, the stent got caught with the implanted stent and dislodged proximal to the implanted stent.A 2.75 x 12 mm nc trek balloon was used to compress the dislodged stent against the vessel wall and a 2.75 x 12 mm xience alpine stent was deployed over the compressed stent which was an intended site planned for stenting.A 2.5 x 12 mm xience alpine was advanced and implanted in the distal lad successfully to complete the procedure.At the end of the procedure, the vessel had great results.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: 7511997
• Report Number: 2024168-2018-03554
• Device Sequence Number: 1695550
• Product Code: NIQ
• UDI-Device Identifier: 08717648199189
• UDI-Public: 08717648199189
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/14/2018

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: 12/05/2020
• Device Catalogue Number: 1125250-23
• Device Lot Number: 7112741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 2.5 X 38 MM XIENCE ALPINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR