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

Model Number	1550350-33
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to advance could not be tested as it was based on operational circumstances.The inner member and outer member (shaft) were stretched distal to the guide wire exit notch.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure, as it is likely the device interacted with the mildly tortuous lesion during advancement resulting in the reported failure to advance.Further interaction with the challenging anatomy and/or guide catheter during retraction of the device likely contributed to the reported material deformation (proximal bent, stretched and flared stent struts) and noted stretched inner/outer member.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 performed to treat a mildly tortuous bifurcation at the distal left main (lm) and proximal left anterior descending (lad) artery.The 3.50x33mm xience sierra stent delivery system was advanced however failed to cross the lesion.The sds was removed without resistance.Outside of the patient, the proximal end of the stent was noted to be lifted.A new xience stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Return device analysis noted the inner and outer member shafts were stretched.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: 9860954
• Report Number: 2024168-2020-02716
• Device Sequence Number: 2373312
• Product Code: NIQ
• UDI-Device Identifier: 08717648227455
• UDI-Public: 08717648227455
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2020
• Device Model Number: 1550350-33
• Device Catalogue Number: 1550350-33
• Device Lot Number: 9062641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR