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

Model Number	1804225-15
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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 heavily calcified, moderately tortuous lesion in the circumflex (cx) artery.A 2.25x15mm xience skypoint drug eluting stent (des) failed to cross the lesion due to anatomical conditions and a dissection was noted.An unspecified balloon was used to complete the procedure.No additional information was provided.
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 did not indicate a lot specific quality issue.The investigation determined the reported failure to advance appears 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.The 2.0x12mm trek balloon dilatation catheter (bdc) referenced in b5 is filed under a separate medwatch report numberb1, h1: an adverse event did not occur.B5: description of event.H6: health effect - clinical code 3160- removed.H6: health effect - impact code 4641 - removed.H6: medical device problem code - 2993 - removed.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was provided.It was reported that the procedure was to treat a heavily calcified, moderately tortuous, 70% stenosed lesion in the circumflex (cx) artery.Pre-dilatation was completed with a 2.0x12mm trek balloon dilatation catheter (bdc) and a non-abbott bdc, after which a 2.25x15mm xience skypoint drug eluting stent (des) failed to cross the lesion due to anatomical conditions.The dissection was not caused by the xience skypoint stent.Imaging was performed and it was noted that a dissection occurred, caused by the 2.0x12mm trek balloon.An unspecified balloon was used to successfully complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.There was no additional information 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: 16134966
• Report Number: 2024168-2023-00379
• Device Sequence Number: 6651416
• Product Code: NIQ
• UDI-Device Identifier: 08717648232992
• UDI-Public: 08717648232992
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 02/02/2023

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: 06/22/2023
• Device Model Number: 1804225-15
• Device Catalogue Number: 1804225-15
• Device Lot Number: 1061041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 56 KG