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

Model Number	1804275-28
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Diaphoresis (2452); Thrombosis/Thrombus (4440)
Date of Event	04/13/2023
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.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported patient-device incompatibility (wall apposition) could not be determined.In addition, a conclusive cause for the reported patient effects, 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 nausea, thrombosis and myocardial infarction 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.
Event or Problem Description
It was reported that the first percutaneous coronary intervention (pci) was performed on (b)(6) 2022 to treat a lesion in the mid left anterior descending (mlad) coronary artery with moderate calcification and mild tortuosity.The 2.75x28mm xience skypoint stent was implanted and the procedure was completed.There was no issue found on the follow up one month later.On the (b)(6) 2023, the patient presented to the hospital with cold sweat and vomiting.Electrocardiogram was performed and the right bundle branch was noted completely blocked, the troponin-t was positive, and myocardial infarction (mi) was confirmed.In stent thrombosis was noted and stent mal-apposition was confirmed via optical coherence tomography (oct).The patient was hospitalized, percutaneous old balloon angioplasty (poba) was performed to treat the thrombosis.The patient was discharged.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported patient-device incompatibility (wall apposition) could not be determined.In addition, a conclusive cause for the reported patient effect(s) of nausea, thrombosis, myocardial infarction, diaphoresis, cardiac enzyme elevation, 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 unrelated death was due to heart failure, and the xience skypoint did not cause or contribute to the patient death.The reported patient effects of nausea, death, thrombosis and myocardial infarction 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.
Event or Problem Description
Subsequent to reports being filed, it was reported that the patient died of heart failure on (b)(6) 2024; however, in the physicians opinion, the xience skypoint stent did no cause or contribute to the death or heart failure.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: 16899462
• Report Number: 2024168-2023-04973
• Device Sequence Number: 15162838
• Product Code: NIQ
• UDI-Device Identifier: 08717648233180
• UDI-Public: (01)08717648233180(17)240720(10)107144A
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 07/20/2024
• Device Model Number: 1804275-28
• Device Catalogue Number: 1804275-28
• Device Lot Number: 107144A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 67 KG