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

Model Number	1804325-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Diaphoresis (2452); Thrombosis/Thrombus (4440)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
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.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to the operational context of the procedure.The reported patient effects of angina, hypotension, myocardial infarction and thrombosis are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience skypoint device referenced in event is being filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat lesions in the in the proximal left anterior descending (plad) artery and proximal ramus intermedius (pri) coronary artery.Activated clotting time (act) was noted to be 303 seconds; therefore, another 2000 units of iv heparin were administered.Additionally, 180mg of brilinta was administered.The 3.25x33mm xience skypoint stent delivery system (sds) was advanced to the target lesion in the plad and the stent was deployed at 18 atm for 12 seconds.Angiography was performed and there was no issue with the implanted stent.Next the 2.25x15mm xience skypoint sds was advanced to the target lesion in the pri and deployed at 12 atm for 15 seconds.The physician took angiographic views post stent implantation.There was no reported issue with the second implanted stent.Post procedure the patient noted chest pain of a 2 on a scale of 10.Sometime post procedure in the holding area, blood pressure was noted to be critically low and the patient was diaphoretic with severe chest pain.Electrocardiogram (ekg/ecg) noted an st-elevation myocardial infarction (stemi).The patient was brought back, emergently, to the cath lab.At some point, the patient lost consciousness and coded.Cardiopulmonary resuscitation (cpr) was performed.Act was noted to be low, so additional heparin was administered.Both stented arteries were noted to be filled with thrombus, so a cangrelor bolus was administered and thrombectomy was performed with additional ballooning.The patient was noted to be in poor condition, so a heart pump temporary pacemaker were inserted.At this point, the patient began to stabilize.Patient was taken in critical, but stable condition to the intensive care unit.In the physician¿s opinion, the cause of the thrombus was malabsorption of p2y12 inhibitor.As of on (b)(6) 2023, the patient is alive, and stable, but remains hospitalized.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: 16613426
• Report Number: 2024168-2023-03026
• Device Sequence Number: 11994801
• Product Code: NIQ
• UDI-Device Identifier: 08717648233357
• UDI-Public: 08717648233357
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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
• Report Date (Section B): 03/24/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 1804325-33
• Device Catalogue Number: 1804325-33
• Device Lot Number: 2032541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention; Disability
• Patient Age: 66 YR
• Patient Sex: Male