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

Model Number	1550225-38
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Thrombosis (2100)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: 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 stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily tortuous and heavily calcified lesion in the second diagonal coronary artery.A 2.75x38mm xience sierra stent delivery system (sds) failed to cross due to the anatomy.The sds was removed without issues.An attempt to advance a 2.25x38mm xience sierra sds was made, however, this too failed to cross due to the anatomy.The patient was re-wired and a guideliner was placed.The same 2.25x38mm xience sierra sds was re-attempted and failed to cross again.During removal of the sds, the stent dislodged and all was removed as a single unit.At the time it was thought that the stent would be in the guideliner; however, this was not the case as the dislodged stent remained in the left anterior descending (lad) coronary artery.The dislodged stent was crushed against the vessel wall via balloon dilatation.The lad then developed thrombus and an attempt to re-wire was made for additional treatment.During re-wiring with an unspecified guide wire, the wire was entering the subintimal lad when a dissection occurred.An impella device was implanted and the patient was sent for a coronary artery bypass graft (cabg).There was no additional adverse patient sequela reported at this time.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 similar incidents from this lot.It should be noted that the xience siera everolimus eluting coronary stent system instruction for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.In this case, it is unknown if the ifu deviation related to reinserting the sds may have contributed to the reported event.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with difficult anatomy during advancement to the lesion causing the reported failure to advance.The device was then removed, a new guide wire and guide liner were added and the device was re-inserted.The device failed to cross the lesion after re-insertion and the stent dislodged during removal causing the reported stent dislodgement with the patient effects of device embedded in vessel, thrombosis, additional therapy/non-surgical treatment, surgical procedure and hospitalization.The reported patient effect of thrombosis is listed in the xience sierra everolimus eluting coronary stent systems ifu as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9511682
• Report Number: 2024168-2019-14931
• Device Sequence Number: 19492541
• Product Code: NIQ
• UDI-Device Identifier: 08717648227066
• UDI-Public: 08717648227066
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 01/22/2020

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: 05/02/2020
• Device Model Number: 1550225-38
• Device Catalogue Number: 1550225-38
• Device Lot Number: 9042641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/22/2020
• 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: GUIDELINER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 103