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

Catalog Number	1125225-18
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.The xience alpine everolimus eluting coronary stent system instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.It is unknown if the ifu deviation contributed to the reported event.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 failure to advance and stent dislodgement appear to be related to circumstances of the procedure.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 an eccentric de novo lesion located in the right coronary artery (rca atrioventricular) that was mildly tortuous, mildly calcified and 90% stenosed.The lesion was pre-dilated with a non-abbott balloon.The xience alpine 2.25 x 18 mm stent delivery system (sds) was advanced towards the lesion but failed to cross a previously implanted stent in the proximal right coronary artery (rca).Although the proximal part was dilated with the non-abbott balloon, the sds failed to cross again.When the sds was removed, the stent implant was found to have dislodged.Under fluoroscopy, it was discovered that the dislodged stent was caught in the stent strut located in the proximal rca.A 3.0 x 15 xience alpine stent was then deployed to crush the dislodged stent.Ivus was performed and stenosis in the atrioventricular went from 90% to 25%.With this confirmed, the procedure was completed.There was no reported adverse patient sequela.There was no reported 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: 7522712
• Report Number: 2024168-2018-03675
• Device Sequence Number: 11228247
• Product Code: NIQ
• UDI-Device Identifier: 08717648199080
• UDI-Public: 08717648199080
• 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): 05/17/2018

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: 10/30/2020
• Device Catalogue Number: 1125225-18
• Device Lot Number: 7101361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 05/17/2018
• 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: GUIDE WIRE: SION BLUEGUIDE CATH: HYPERION
• Outcome Attributed to Adverse Event: Required Intervention