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

Model Number	1804225-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Myocardial Infarction (1969)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2021 the patient underwent a coronary intervention.The lesion was confirmed with intravascular ultrasound (ivus) and the 2.25x23 mm xience skypoint stent was implanted at 12 atmospheres in the left anterior descending (lad) coronary artery.The lesion was more than 20mm, eccentric, mild tortuosity, mild calcification, no-entrance location, no branches, no thrombosis, non chronic totally occluded (cto) lesion.A balloon was used for post dilatation per standard practice.The next day, on (b)(6) 2021, the patient was still in the hospital and they experienced a myocardial infarction in the lad.Hematoma was also found 5 mm distal to the distal part of the stent.Impaired flow of blood was noted on the main trunk.There was no remark of stent thrombosis and blood circulation did not improve.At occurrence of the event, three anti-platelets (prasugrel, aspirin, and doac) were prescribed (one for each).There was no other treatment performed.It is unknown if the hospitalization was increased due to the issues.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2021 the patient underwent a coronary intervention.The lesion was confirmed with intravascular ultrasound (ivus) and the 2.25x23 mm xience skypoint stent was implanted at 12 atmospheres in the left anterior descending (lad) coronary artery.The lesion was more than 20mm, eccentric, with mild tortuosity, mild calcification, in a no-entrance location, no branches, no thrombosis, non chronic totally occluded (cto).A balloon was used for post dilatation per standard practice.The next day, (b)(6) 2021, the patient was still in the hospital and they experienced a myocardial infarction in the lad.Hematoma was also found 5 mm distal to the distal part of the stent.Impaired flow of blood was noted on the main trunk.There was no remark of stent thrombosis and blood circulation did not improve.At occurrence of the event, three anti-platelet medications (prasugrel, aspirin, and doac) were prescribed (one for each).There was no other treatment performed.It is unknown if the hospitalization was increased due to the issues.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of myocardial infarction and hematoma are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) 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 reported 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.

• 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: 13040113
• Report Number: 2024168-2021-11854
• Device Sequence Number: 12124794
• Product Code: NIQ
• UDI-Device Identifier: 08717648233012
• UDI-Public: 08717648233012
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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 Model Number: 1804225-23
• Device Catalogue Number: 1804225-23
• 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: 12/01/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/18/2021
• Supplement Report FDA Received Date: 01/25/2022
• 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: Hospitalization; Disability
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 69 KG