MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1550350-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The reported patient effect of occlusion is listed in the xience sierra, everolimus eluting coronary stent system, instructions for use, as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The additional abbott devices referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the heavily calcified, moderately tortuous circumflex coronary artery.Before the procedure, a mini trek bdc was opened during prep and it was noted that the balloon was separated from the shaft.The device was not used and there was no patient involvement.A 3.5 x 23 mm xience sierra was implanted without issue; however, wire position was lost as the vessel closed for an unknown reason.A new balance middleweight (bmw) guide wire was advanced as well as a whisper guide wire and the whisper was thought to be in the true lumen of the vessel.The bmw went under and around a couple struts of the previously implanted xience sierra stent and over the whisper guide wire.The bmw was then jailed with a 2.25 x 18 mm xience sierra stent.The bmw was stuck and was not able to be removed.Balloon angioplasty was attempted in order to free the guide wire but it was unsuccessful.The bmw then separated and coiled into a ball.The tip of the whisper guide wire also separated due to the bmw guide wire wrapping around it.The separated portions of the guide wires both remain in the patient anatomy.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9130975
• Report Number: 2024168-2019-12174
• Device Sequence Number: 19445429
• Product Code: NIQ
• UDI-Device Identifier: 08717648227431
• UDI-Public: 08717648227431
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1550350-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/27/2019
• 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