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

Model Number	1550350-12
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal right coronary artery (rca) and the ostial rca without calcification or tortuosity.Two xience sierra stents, 2.25x23mm and 3.5x12mm, were advanced without resistance and implanted.However, the distal end of the 3.5x12mm xience sierra stent deployed in the ostial rca was hard to visualize during contrast injections and the stent placement was a geographical miss.The distal end of the stent was barely attached to the vessel wall and once the stent delivery system and guide wire were removed without resistance, the stent dislodged.Since the stent cannot be visualized, the dislodged stent was unable to be retrieved and no attempts were made.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.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.The product was not returned to abbott vascular for analysis as it was discarded by the account.Factors that may cause difficulty visualizing the balloon under fluoroscopy include, but not limited to, the type of contrast solution, missing marker bands, material discrepancies with the balloon markers, patient anatomy, patient disease state, fluoroscopy equipment, and the angle of the x-ray tube on the patient.Factors that may contribute to difficulty deploying the stent leading to stent migration include but are not limited to improper/inadequate crimping at the time of manufacture, patient anatomical morphology, patient disease state, pre-dilatation strategy, inflation, interactions with the patient anatomy, balloon ruptures / leaks, or under-sizing of the vessel.There was no damage noted to the sds or stent during the inspection prior to use which suggests a product deficiency did not contribute to the reported difficulties.The reported poor visibility resulted in the inability to visualize where the dislodged stent migrated to; therefore the stent was not retrieved.The investigation was unable to determine a conclusive cause for the reported poor visibility and stent migration.The reported foreign body in patient and serious illness/impairment/injury appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16834917
• Report Number: 2024168-2023-04459
• Device Sequence Number: 15330566
• Product Code: NIQ
• UDI-Device Identifier: 08717648227400
• UDI-Public: 08717648227400
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: 04/25/2023
• Device Model Number: 1550350-12
• Device Catalogue Number: 1550350-12
• Device Lot Number: 1042141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.25X23MM XIENCE SIERRA STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 84 KG