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 Codes	Angina (1710); Thrombosis/Thrombus (4440)
Date of Event	02/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that in (b)(6) 2023, a 2.0x30mm non-abbott stent was implanted in the right coronary artery.Patient was placed on an anti-platelet medication.On (b)(6) 2023, the patient was rehospitalized and thrombus was noted in the non-abbott stent.A 3.5x18mm xience skypoint stent was implanted as treatment, and the anti-platelet medication was changed.On (b)(6) 2023, the patient was rehospitalized with chest pain.Thrombosis was noted in the xience skypoint stent.Balloon angioplasty was performed and the anitplatelet medication was changed again.Additionally, it was noted that the patient was non-compliant with the antiplatelet medication.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record for this product was not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effects of thrombosis and angina are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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.B2: outcomes attributed to ae - hospitalization added.H6: health effect - impact code - 4607 added.

• 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: 16585020
• Report Number: 2024168-2023-02922
• Device Sequence Number: 1635559
• Product Code: NIQ
• UDI-Device Identifier: 08717648233401
• UDI-Public: 08717648233401
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/27/2023

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: 1804350-18
• Device Catalogue Number: 1804350-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/27/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.0X30MM ONYX RESOLUTE STENT.; BRILINTA.; EFFIENT.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Black Or African American