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

Model Number	1804250-18
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
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 identified no other incidents.The reported patient effect of dissection is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.In this case, it is likely the device interacted with the heavily calcified and moderately tortuous lesion during advancement resulting in the reported failure to advance and subsequent patient effect of dissection with unexpected medical intervention.The investigation determined the reported failure to advance and subsequent treatment appears to be related to the operational context of the procedure.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 the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the patient presented in cardiac arrest, being resuscitated due to an st-elevated myocardial infarction (stemi) in the left main.It was noted that the lesion in the left main artery was heavily calcified and moderately tortuous.Two guide wires were advanced through the left main, one down the left anterior descending(lad) artery and one down the ramus intermedius (ri) artery.Four xience skypoint stents (2-2.5x18, 2-3.0x18) were attempted, but failed to reach the lesion at some point during the procedure, a dissection was noted; however, it was unknown what caused it.The dissection was treated with a non-abbott stent.There was no adverse patient sequela and post procedure the patient status was good and the patient was stable.No additional information has been 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: 14888318
• Report Number: 2024168-2022-07175
• Device Sequence Number: 15023498
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: 08717648233081
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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
• Report Date (Section B): 07/01/2022

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: 01/18/2024
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 2011341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.50X18MM XIENCE SKYPOINT STENT; 3.00X18MM XIENCE SKYPOINT STENT; 3.00X18MM XIENCE SKYPOINT STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown