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

Model Number	1550350-38
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis as the stent remains in the patient.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 identified no similar incidents from this lot.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of occlusion is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures.In this case, it is likely the tip of the guide catheter went underneath the stent during deployment, thus causing the reported device damaged by another device and material deformation.Based on the information reviewed, 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 this was a percutaneous coronary interventional procedure in the vein graft to the obtuse marginal coronary artery.The patient came in emergently and was in an unstable condition.Before the stenting procedure began, the patient was defibrillated to resolve an arrhythmia the patient had.Several stents were implanted in the vein graft and the last stent was in the ostium of the graft, the 3.5x38 mm xience sierra.The stent was implanted without issue and the delivery system was removed.The procedure was completed and the guide catheter was attempted to be removed but was stuck.When the guide catheter was removed, damage to the implanted 3.5x38 sierra stent was noted.It was suspected that the tip of the guide catheter somehow got underneath the stent during deployment.Additional balloon angioplasty was performed in the damaged stent, but it did not improve the flow.They decided to treat an unplanned artery to improve the patient's blood flow from other vessels as much as possible.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: 9936160
• Report Number: 2024168-2020-03482
• Device Sequence Number: 19512474
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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: 10/22/2020
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 9101642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/08/2020
• 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: 69 YR
• Patient Weight: 99