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

Model Number	1550225-15
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The stent remains in patient.The device will not be returned for evaluation.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 to treat a right coronary artery (rca).A 3.5x33mm xience sierra was first deployed successfully with no issues in the proximal rca.A second 2.25x15mm xience sierra was attempted to be delivered through the first deployed stent; however, resistance was met with stent.During removal of the second xience sierra the stent dislodged.Case lasted from 5 p.M.To 1 a.M.And patient was transferred to a different hospital as the doctor couldn't cross another stent to crush the second xience stent.Once at the other hospital the dislodged stent was crushed into the vessel wall.Patient is doing well.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 the reported difficulties and subsequent treatments appear to be related to circumstances of the procedure.In this case, it is likely that the stent interacted with the previously implanted stent during retraction, causing the reported stent dislodgement which contributed to the reported difficult to remove.Once at the other hospital, the dislodged stent was crushed into the vessel wall.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11405095
• Report Number: 2024168-2021-01666
• Device Sequence Number: 19675972
• Product Code: NIQ
• UDI-Device Identifier: 08717648227011
• UDI-Public: 08717648227011
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: 01/27/2022
• Device Model Number: 1550225-15
• Device Catalogue Number: 1550225-15
• Device Lot Number: 0071741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/05/2021
• 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: 3.35X33MM XIENCE SIERRA; 3.35X33MM XIENCE SIERRA
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention