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

Model Number 1804275-28

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Diaphoresis (2452); Thrombosis/Thrombus (4440)

Event Date 04/13/2023

Event Type  Injury  

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 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.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: 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
• MDR Text Key: 314885436
• Report Number: 2024168-2023-04973
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233180
• UDI-Public: 08717648233180
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 67 KG