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

Catalog Number	1804300-08
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the circumflex coronary artery with no calcification and no tortuosity.The 3.0x08 xience skypoint stent delivery system (sds) was advanced to the lesion and then prepped.Inflation was attempted.The balloon was able to get to 16 atmospheres after one inflation; however, the device was not holding pressure and a rupture was noted.The stent was 90% deployed.A non-compliant (nc) balloon was used for post-dilatation to complete deployment of the stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier: incorrect prep.
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 investigation was unable to determine a conclusive cause for the reported difficulties.The reported treatment appears to be related to operational context of the procedure.It was reported xience skypoint stent delivery system (sds) was advanced to the lesion and then prepped, and then inflation was attempted.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: while introducing the delivery system into the vessel, do not induce negative pressure on the delivery system.This may cause dislodgement of the stent from the balloon.In this case, it does not appear the instruction for use (ifu) deviation related to incorrect stent preparation contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the circumflex coronary artery with no calcification and no tortuosity.The 3.0x08 xience skypoint stent delivery system (sds) was advanced to the lesion and then prepped, and then inflation was attempted.The balloon was able to get to 16 atmospheres after one inflation; however, the device was not holding pressure and a rupture was noted.The stent was 90% deployed.A non-compliant (nc) balloon was used for post-dilatation to complete deployment of the stent.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 17671692
• Report Number: 2024168-2023-09575
• Device Sequence Number: 6434965
• Product Code: NIQ
• UDI-Device Identifier: 08717648233210
• UDI-Public: 08717648233210
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 10/06/2023

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: 04/04/2026
• Device Catalogue Number: 1804300-08
• Device Lot Number: 3041341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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: NON-COMPLIANT (NC) BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown