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

Model Number	1804350-18
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) coronary artery with calcification and 99% stenosis.The 3.5x18 mm xience skypoint stent delivery system (sds) failed to cross the lesion due to the anatomy and the distal part of the stent struts broke but did not separate.The device was simply withdrawn.A new xience skypoint sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) coronary artery with calcification and 99% stenosis.The 3.5x18 mm xience skypoint stent delivery system (sds) failed to cross the lesion due to the anatomy and the distal part of the stent struts broke but did not separate.The device was simply withdrawn.A new xience skypoint sds was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Subsequent to fiing the initial report, an additional 3.5x18 mm xience skypoint sds was received in the returned goods lab but it was only prepped and had not been used in the patient.The struts at the proximal end of the stent implant were bent and stretched distally.There were bends in the hypotube.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9: device available for evaluation updated from yes to no.H3: reason device not evaluated by mfg updated to 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: 17299071
• Report Number: 2024168-2023-07346
• Device Sequence Number: 12521710
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• UDI-Public: 08717648233401
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• 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): 08/24/2023

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: 09/04/2024
• Device Model Number: 1804350-18
• Device Catalogue Number: 1804350-18
• Device Lot Number: 2091241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2022
• 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
• Patient Sex: Unknown