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

Model Number	1804300-23
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	11/18/2022
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.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of stenosis and angina are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as a known patient effect of coronary stenting procedures.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the ostial left anterior descending (lad) artery with in-stent restenosis.On (b)(6) 2021, a 3.0x23mm xience skypoint stent was implanted and post dilated to 3.5 at that time.The patient was medically compliant and according to the notes it was not stopped or interrupted.The patient was taking aspirin (81 mg) and clopidogrel (75 mg).On (b)(6) 2022, the patient came back with restenosis of the xience skypoint stent which was discovered because the patient was symptomatic with worsening angina during activity and rest.Angiography was done to confirm restenosis.Also, there was a diagonal branch with mild calcification and mild tortuosity that was covered by the xience skypoint stent when it was deployed across the entire lad in 2021 that the physician wanted to dilate.The 2.5x20mm trek rx balloon dilatation catheter (bdc) was advanced but as it entered the vessel and reached the stent, the entire system was kicked out and the bdc was noted to be kinked.After rewiring the lad, the procedure for the diagonal branch was aborted to treat the restenosis.The re-stenosed area was ballooned and a 3.5x18mm non-abbott stent was implanted.Patient was released the next day per standard procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.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: 15974310
• Report Number: 2024168-2022-12594
• Device Sequence Number: 6959765
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: 08717648233258
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/13/2022

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: 04/11/2023
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 1040641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.5X20MM TREK RX BALLOON
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 57 KG