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

Model Number	1550350-33
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Attachment: fda letter/sus voluntary event report (mw5092968).
Event or Problem Description
It was reported that the procedure was performed to treat a lesion with mild tortuosity and mild calcification in the right coronary artery (rca).The stent delivery system (sds) was advanced to the target lesion without issue.The sds was pressurized to nominal pressure, but the stent did not deploy.There was no stent on the balloon.The dislodged stent was found on the back table where the sds had been prepared for use.There was no resistance noted during removal of the protective sheath.Another sds was used to complete the procedure successfully.There was no adverse patient effect.There was no clinically significant delay in the procedure.Additionally, a sus voluntary event report (mw5092968) was received reporting: xience sierra stent was to be utilized for pci of rca.Stent was prepped in the usual fashion and device was placed into the pt in normal fashion.After balloon inflation and attempted stent deployment it was determined that the stent was no present in the artery as expected.Upon further investigation, the stent was found having never been inserted into the pt.It was apparent that the stent had been dislodged from teh delivery balloon and was found on the sterile procedure table.Fda safety report id #(b) (4).No additional information was provided.
Additional Manufacturer Narrative
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 from this lot.As reportedly there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after the inspection prior to use inadvertent mishandling during preparation for use resulted in the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10.The device was initially reported as returning, but has now been reported as not returning.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• 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: 9818840
• Report Number: 2024168-2020-02266
• Device Sequence Number: 11155085
• Product Code: NIQ
• UDI-Device Identifier: 08717648227455
• UDI-Public: 08717648227455
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 07/25/2020

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: 10/28/2020
• Device Model Number: 1550350-33
• Device Catalogue Number: 1550350-33
• Device Lot Number: 9102141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/13/2020; 07/20/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 05/22/2020; 07/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1