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

Model Number	1550225-33
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 to treat a mildly calcified, heavily tortuous left anterior descending artery (lad).On (b)(6) 2020, a 2.25x33mm xience sierra was implanted at the lesion without issue.During the follow up visit on (b)(6) 2021, the physician noted that the stent implant was fractured in two separate pieces and had migrated a bit distally, still remaining on the lad target lesion.No treatment has been performed.No distal flow interruption was noted.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulties; however, potential causes for material separation, detachment of device or break include, but are not limited to, damage during manufacturing, damage to the device during shipping/receiving, inadvertent mishandling during repackaging, patient anatomical morphology, deployment technique, sheath/stylet removal, during preparation or use of the device.In addition, factors that may contribute to stent migration include, but are not limited to, patient anatomical morphology, patient disease state, non-uniform or partial stent apposition or under-sizing of the vessel.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the films sent for review were dated (b)(6) 2020 and (b)(6) 2021.Since the initial film from (b)(6) 2020 was not provided, the reviewer could not confirm or deny that it was a single stent in the lad or there was more than one stent placed in the lad.The images provided revealed 2 separate areas within the lad where there is a stent placed but, without the initial images, the reviewer could not confirm the stent itself fractured or migrated.In this case, it is possible that the anatomical morphology of the patient contributed to the reported material separation (stent break/fracture), causing a portion of the stent to migrate distally from where it was originally placed in the lesion; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no product-related corrective action will be implemented in this case.Na.

• 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: 11362658
• Report Number: 2024168-2021-01366
• Device Sequence Number: 11606002
• Product Code: NIQ
• UDI-Device Identifier: 08717648227059
• UDI-Public: 08717648227059
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/26/2021

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 Model Number: 1550225-33
• Device Catalogue Number: 1550225-33
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1