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

Model Number	1804250-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 88 year old female patient presented in a poor condition with severe heart failure, difficulty breathing, small and narrow vessels with diffuse disease throughout the heart.The patient has a recent failed revascularization procedure at another hospital, so this revascularization procedure was noted to be at last option.Initially, the left anterior descending artery (lad) was treated with a skypoint stent and a 2.25x8mm non-abbott stent was implanted in the first diagonal; however, the lesion in the first diagonal artery restenosed within minutes.Attempts to open the 1st diagonal were unsuccessful.Next, the right coronary artery (rca) was treated.A 2.25x8mm xience skypoint stent was implanted in the proximal posterior descending artery (pda), followed by implantation of a 2.50x38mm xience skypoint in the mid rca and then a 3.00x12mm xience skypoint stent in the proximal ostial rca.Post stent implantation the 2.5x38mm xience skypoint stent implanted in the mid rca started clotting off.A non-compliant balloon was used to re-open the rca with intermediate success.There was blood flow in the rca, but the patient began to lose pressure, and went into ventricular fibrillation, so cardiopulmonary resuscitation was started.The patient was shocked and chest compressions were performed.A heart pump and pacing catheter were inserted.Additional balloons were used to attempt to re-open the rca as well as additional chest compressions.The patient never recovered from ventricular fibrillation and, after about an hour the patient expired.The patient's activating clotting time (act) was 266.Per the physician, the abbott stents did not cause the patient death as the patient was very sick and the procedure was known to be a high risk for the patient.No additional information was provided.
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 and death 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.Per the physician, the abbott stents did not cause the patient death as the patient was very sick and the procedure was known to be a high risk for the patient.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the physician noted that the abbott stents did not cause the patient death.The reported treatment appears to be related to the operational context of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
N/a.

• 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: 16207107
• Report Number: 2024168-2023-00689
• Device Sequence Number: 5454688
• Product Code: NIQ
• UDI-Device Identifier: 08717648233128
• UDI-Public: 08717648233128
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 02/10/2023

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 Expiration Date: 07/24/2024
• Device Model Number: 1804250-38
• Device Catalogue Number: 1804250-38
• Device Lot Number: 2071841
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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: 2.50X38MM XIENCE SKYPOINT STENT PART# 1804250-38.; XIENCE SKYPOINT DES 2.25 X 08 STENT PART# 1804225.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 77 KG