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

Model Number	1804250-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal, mid, and proximal left anterior descending (lad) artery with heavy calcification and moderate tortuosity.The 2.5x38mm xience skypoint stent delivery system (sds) was implanted in the distal lad artery.The second xience skypoint stent, 2.75x38mm, was implanted in the mid lad artery.The third xience skypoint stent, 3.0x28mm, was implanted in the mid to proximal lad artery.All three stents were post dilated using a 2.5x25mm nc trek neo balloon dilatation catheter (bdc) at the distal part of the lesion and a 3.0x25mm nc trek neo bdc at the proximal part of the lesion.Angiogram was used to confirm that the stents were fully apposed.At this time it was noted there was a distal edge dissection on the most distal 2.5x38mm implanted stent.An additional 2.25x18mm xience skypoint stent was attempted to be used to treat the dissection and crossed the proximal segment (3.0x28mm stent) but failed to cross the 2.75x38mm implanted stent and the struts became flared.Further post dilatation was performed for the 3 implanted stents per standard procedure.A wiggle wire was used as a buddy wire and another 2.25x18mm xience skypoint stent was implanted to treat the dissection.Angiogram was used to confirm final results.There was no adverse patient sequelae and there was no clinically significant delay in 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.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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment 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.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: 16444373
• Report Number: 2024168-2023-01953
• Device Sequence Number: 5599621
• Product Code: NIQ
• UDI-Device Identifier: 08717648233128
• UDI-Public: 08717648233128
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/27/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1804250-38
• Device Catalogue Number: 1804250-38
• Device Lot Number: 2090541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 83 KG