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

Catalog Number	1125250-12
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2018
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 revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined that the reported difficulties and subsequent treatments 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 de novo lesions located in the circumflex and bifurcation of the circumflex, the left main which was 80% stenosed, and the left anterior descending artery using xience alpine stent delivery systems (sds).Reportedly, a 2.5 x 28 mm and 2.5 x 15 mm xience alpine were attempted to cross; however, neither sds would cross due to the 80% stenosis in the left main.The decision was made to place a 4.0 x 15 mm xience alpine in the left main to facilitate the crossing of the sds.An attempt was made to cross with a 2.5 x 12 mm xience alpine which crossed through the deployed stent easily; however, did not reach the lesion.During retraction of the stent delivery system, the stent implant caught inside the deployed stent causing the stent to dislodge from the balloon.A snare device was used in an attempt to capture the stent implant; however, this failed.A non-abbott balloon catheter was advanced and inflated inside the dislodged stent and the stent was deployed inside the 4.0 x 15 mm stent.The procedure continued on with the successful placement of three non-abbott stents.The patient was stable post-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: 7456951
• Report Number: 2024168-2018-03035
• Device Sequence Number: 13739795
• Product Code: NIQ
• UDI-Device Identifier: 08717648199158
• UDI-Public: 08717648199158
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 07/25/2020
• Device Catalogue Number: 1125250-12
• Device Lot Number: 7071341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/24/2018
• 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
• Patient Age: 75 YR
• Patient Weight: 89