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

Model Number	1804225-18
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with 90% stenosis, moderate calcification and moderate tortuosity.The 2.25x18mm xience skypoint stent delivery system (sds) was advanced, however, failed to cross the lesion.There was no resistance during removal of the sds.Once removed from the patient, it was noted the proximal end of the stent looked like it was lifted off the balloon.Another xience skypoint of the same size was used to complete the procedure.A dissection was noted post deployment/post dilatation but was not visible following removal of the device.The dissection was thought to have occurred when the first xience skypoint was advanced and failed to cross but was not noticed until after use of the second xience skypoint.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to advance could not be tested as it was based on operational context.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 of the reported lot did not indicate a lot specific quality issue.The reported patient effect of dissection is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties appear to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: medical device problem code 2923 removed; 2976 added.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with 90% stenosis, moderate calcification and moderate tortuosity.The 2.25x18mm xience skypoint stent delivery system (sds) was advanced, however, failed to cross the lesion.There was no resistance during removal of the sds.Once removed from the patient, it was noted the proximal end of the stent looked like it was lifted off the balloon.Another xience skypoint of the same size was used to complete the procedure.A dissection was noted post deployment/post dilatation but was not visible following removal of the device.The dissection was thought to have occurred when the first xience skypoint was advanced and failed to cross but was not noticed until after use of the second xience skypoint.There was no adverse patient sequela and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the proximal edge of the stent was sticking up [flared] and not dislodged.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: 15093734
• Report Number: 2024168-2022-08085
• Device Sequence Number: 4034923
• Product Code: NIQ
• UDI-Device Identifier: 08717648233005
• UDI-Public: 08717648233005
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 08/24/2022

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: 11/23/2023
• Device Model Number: 1804225-18
• Device Catalogue Number: 1804225-18
• Device Lot Number: 1111641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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: Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 88 KG