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

Catalog Number	1125350-15
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	01/18/2017
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.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 identified no other similar incidents reported from this lot.The investigation determined the reported stent dislodgement and the reported difficulty to remove 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 a de novo lesion in the non-tortuous, non-calcified, proximal right coronary artery (rca).A 3.50 x 15 mm xience alpine stent delivery system (sds) was selected for the procedure.The sds was advanced to the lesion and crossed.While pulling back the sds to position the stent implant, the edge of the stent implant caught on the end of the guiding catheter and dislodged.An unspecified snare was used in five attempts to retrieve the dislodged stent, however the attempts were unsuccessful.A non-abbott stent implant was used to crush and embed the xience alpine stent implant to the vessel wall.There was a 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: 6323703
• Report Number: 2024168-2017-01123
• Device Sequence Number: 13597556
• Product Code: NIQ
• UDI-Device Identifier: 08717648199523
• UDI-Public: (01)08717648199523(17)190504(10)6042241
• 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): 02/10/2017

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: 05/04/2019
• Device Catalogue Number: 1125350-15
• Device Lot Number: 6042241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/10/2017
• 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 CATHETER: LAUNCHER
• Outcome Attributed to Adverse Event: Required Intervention