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

Model Number	1804300-23
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code 2017 - incorrect prep.The device is expected to be returned for evaluation.It has not yet been received.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 de novo lesion in the proximal left anterior descending (plad) artery.The 3.0x23mm xience skypoint stent delivery system (sds) was soaked in saline and was prepped (air aspiration) inside the anatomy prior to use.No resistance was met when the protective sheath was removed.The sds was advanced without resistance and the balloon inflated once at 8 atmospheres (atms) and then deflation occurred due to a pinhole rupture.The stent was partially deployed and unable to be removed so it was forcedly expanded and implanted.Post dilatation was performed due to the rupture and inadequate stent deployment.There was no resistance during removal.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported material rupture was confirmed.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 other incidents.It was reported that the sds was not prepared (air aspiration) outside the anatomy.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use states: prepare an inflation device / syringe with diluted contrast medium.Attach an inflation device / syringe to the stopcock; attach to the inflation port.With the tip down, orient the delivery system vertically.Open the stopcock to delivery system; pull negative for 30 seconds; release to neutral for contrast fill.Close the stopcock to the delivery system; purge the inflation device / syringe of all air.Repeat steps until all air is expelled.It is unknown if the ifu deviation directly caused or contributed to the reported event.A conclusive cause for the reported material rupture could not be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.Factors that may contribute to material ruptures include, but are not limited to, material damage, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible that interaction between the device and accessory devices and/or the patient anatomy may have caused the observed scratches on the balloon material, ultimately causing the reported material rupture; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• 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: 16449034
• Report Number: 2024168-2023-02023
• Device Sequence Number: 14913976
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: 08717648233258
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2023

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: 08/10/2025
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 2080541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown