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

Model Number	1804350-23
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/31/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2023, an unspecified xience stent was implanted in the 85-90% stenosed, heavily calcified left main to the left anterior descending coronary artery; however, due to the heavy calcification, the stent was under-expanded and not well apposed to the vessel wall.The patient may have developed in-stent thrombosis and died on (b)(6) 2023.No additional information was provided.
Additional Manufacturer Narrative
The unique device identifier (udi) is unknown because the part number and lot number were not provided.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
Subsequent to the previously filed report, the following information was received: the patient was on dual antiplatelet therapy (dapt) of aspirin and plavix, pre and post loaded prior to the case.The patient was on cardiac support during the procedure.Pre-dilatation was performed prior to implanting the 3.5 x 23 mm xience skypoint stent.The stent was post-dilated to 4.0mm.The patient also had unspecified bleeding in the iliac artery during this procedure requiring a covered stent.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.Additionally, a review of the complaint history identified no similar incidents from this lot.A medical review and cine review was performed by an abbott vascular clinical specialist.The reviewer concluded the most likely cause of death for this patient is acute stent thrombosis secondary to stent under expansion due to heavy calcification.Additionally, the possibility of dissection in the left main may have contributed to the thrombosis.However, this can not be definitively stated due to the poor quality of the video provided.It can be definitively stated that the thrombosis was unrelated to xience skypoint.The patient¿s death was due to acute thrombosis with a combination of their advanced age, severely advanced coronary artery disease, not being a surgical candidate, and the possibility of a left main dissection.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition).The reported patient effects of thrombosis and death 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.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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: 16444197
• Report Number: 2024168-2023-01946
• Device Sequence Number: 5835610
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: 08717648233418
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 04/26/2023

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 Model Number: 1804350-23
• Device Catalogue Number: 1804350-23
• Device Lot Number: 2080341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/26/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male