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

Model Number	1804225-08
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.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 an 80% stenosed, mildly calcified and mildly tortuous vessel in the circumflex artery.The 2.25x8mm xience skypoint stent delivery system (sds) was attempted to be placed distally in the vessel after two other stents were already deployed in the target lesion.However, there was resistance during advancement and it was noted that there was difficulty crossing the implanted stents.When it was being pulled back out, the sds got stuck and was difficult to remove from the guiding catheter but was able to get the stent out.The sds was removed as a single unit.The stent was noted to be flared and some stent struts fractured but not separated.The procedure was stopped at this point and patient scheduled for another stenting attempt.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material deformation was confirmed.The reported stent break was not confirmed.The reported failure to advance could not be replicated in a testing environment.The reported difficulty to remove could not be confirmed due to the condition the device was received for evaluation.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 was reported the xience skypoint stent delivery system (sds) was attempted to cross distal to two previously placed stents; however, resistance with the previously placed stents was noted during attempted advancement.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use (ifu) states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent during placement of the distal stent and reduces the chance of damaging or dislodging the proximal stent.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the previously placed stents causing the reported failure to advance.During removal resistance was met with the guiding catheter causing the reported difficult to remove and subsequent material deformation.A conclusive cause for the reported stent break could not be determined as a stent break was unconfirmed during return evaluation of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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: 12920935
• Report Number: 2024168-2021-11019
• Device Sequence Number: 4983002
• Product Code: NIQ
• UDI-Device Identifier: 08717648232978
• UDI-Public: 08717648232978
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/11/2022

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: 03/31/2023
• Device Model Number: 1804225-08
• Device Catalogue Number: 1804225-08
• Device Lot Number: 1032541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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
• Patient Sex: Unknown