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

Model Number	1804350-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
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(s) of occlusion is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.The additional xience skypoint device is filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the complete occlusion of the left anterior tibial and peroneal arteries.A 6fr 45 cm sheath was used as well as thrombectomy and a 3.5x18 mm xience skypoint stent was deployed successfully in the distal popliteal artery; however, the anterior tibial artery (ata) had decreased flow and was jailed off after deployment.A twin pass catheter was used to aid in wiring the ata.A 3.0x20 mm trek balloon was used for pre-dilatation to 18 atmospheres and a 3.5x15 mm xience skypoint stent was deployed to the ostial to proximal ata.A small perforation was noted in the mid ata so a 3.5x19 mm graftmaster covered stent was deployed without issue and final angiogram showed excellent flow with vessel runoff to the ankle.The patient tolerated the procedure well.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: 16024263
• Report Number: 2024168-2022-12943
• Device Sequence Number: 20556532
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• UDI-Public: 08717648233401
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/21/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2024
• Device Model Number: 1804350-18
• Device Catalogue Number: 1804350-18
• Device Lot Number: 2051842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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: 6FR 45 CM SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 97 KG