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

Model Number	1804250-33
Medical Device Problem Codes	Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a 75% stenosed lesion in the distal left anterior descending artery (p, dlad).Pre-dilatation was performed with a non-abbott balloon.Then the 2.50x33mm xience skypoint stent delivery system (sds) was advanced to the target lesion and inflation was attempted to 14 atmospheres (atm) for 5 seconds; however, the stent did no deploy; therefore, an indeflator was used to inflate the balloon for a second time to 14 atm.The stent was successfully implanted, but the balloon was noted to be losing pressure.Additionally, a perforation was noted at the distal end of the implanted stent.A non-abbott perfusion balloon was used to treat the perforation.There was no adverse patient sequela.An additional xience skypoint was implanted in the proximal lad to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material rupture and activation failure including expansion failures was confirmed.Additionally, scratches were noted on the balloon.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/complaints from this lot.The reported patient effect of perforation is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.In this case, return analysis noted scratches on the balloon and torn material, indicating the balloon potentially interacted with the mildly tortuous and 75% stenosed lesion or an accessory device during the procedure.Interaction between the balloon and the anatomy/device likely resulted in the reported balloon rupture and difficulty during balloon inflation.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
N/a.

• 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: 16073415
• Report Number: 2024168-2022-13180
• Device Sequence Number: 12335873
• Product Code: NIQ
• UDI-Device Identifier: 08717648233111
• UDI-Public: 08717648233111
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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: 09/02/2023
• Device Model Number: 1804250-33
• Device Catalogue Number: 1804250-33
• Device Lot Number: 0082741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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