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

Catalog Number	1125400-12
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
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.Expiration date, manufacturing date and manufacturing sites have been provided for both stents: lot #: 6051841, expiration date: 05/29/2019, manufacturing date: 05/2016, manufacturing site: (b)(4).Lot #: 8010861, expiration date: 01/25/2021, manufacturing date: 01/2018, manufacturing site: (b)(4).The device was not returned for analysis.A review of the lot history records identified no manufacturing nonconformities issued to the reported lots that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from either lot.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.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 a 75% stenosed, concentric, moderately calcified lesion in the heavily tortuous circumflex coronary artery.A 4.0x12 mm xience alpine stent was being advanced through a non-abbott guide catheter extension and the stent dislodged proximal to the target lesion.When the stent dislodged it was pushed off the distal side of the balloon.An attempt was made to retrieve the stent using a snare, but failed and the stent was ultimately deployed in the region where it dislodged, partially in the target lesion.Two more xience alpine stents, a 4.0x12 mm and a 4.0x15 mm were successfully deployed to treat the target lesion as planned.The dislodged stent partially overlapped them.The patient outcome is reported as recovered and discharged from the hospital.Reportedly, since two 4.0x12 mm xience alpine stents were used during the procedure (lot 6051841 and 8010861), the lot number for the dislodged stent could not be identified.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: 8255125
• Report Number: 2024168-2019-00391
• Device Sequence Number: 16632586
• Product Code: NIQ
• UDI-Device Identifier: 08717648199608
• UDI-Public: 08717648199608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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 Catalogue Number: 1125400-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/16/2019
• 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