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

Model Number	1804300-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	09/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous, 90% stenosed lesion in the mid right coronary artery (mrca).Medications were provided and a 2.5x28mm xience skypoint drug eluting stent (des) was placed in the mrca, and a 3x15mm skypoint des was placed proximal to that stent.A 3.5x12mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation and the patient was transferred to their room for recovery.Approximately 2 minutes after the patient was transferred to their room, and experienced chest pain.An electrocardiogram (ekg) was performed which indicated an st-elevation myocardial infarction.The patient was immediately placed back in the cath lab for the second time that day.Upon engaging the rca with a guide catheter (gc) it was discovered there was a heavy thrombus throughout the length of the vessel, inside and outside of the recently implanted stents.Medications were provided and a 3.5x15mm skypoint des and a 3.0x15mm skypoint des were implanted proximal to the initial 2 stents in the mrca.Post-dilatation was performed.After the procedure was completed, the act resulted at 248 seconds.The patient was stable without chest pain and transferred back to their room for continued recovery.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 lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of thrombosis/thrombus, myocardial infarction and angina are listed in the xience skypoint instruction for use (ifu) 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.The 2.5x28mm xience skypoint stent referenced is filed under a separate medwatch report number.

• 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: 15655873
• Report Number: 2024168-2022-10935
• Device Sequence Number: 20342582
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: 08717648233234
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 10/21/2022

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: 08/11/2023
• Device Model Number: 1804300-15
• Device Catalogue Number: 1804300-15
• Device Lot Number: 1080541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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: 3.5 X 12 NC TREK
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male