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

Model Number 1804350-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 05/21/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that on the (b)(6) 2022, a percutaneous coronary intervention (pci) was performed in the mid left anterior descending artery (lad) and two non-abbott stents were implanted.On (b)(6) 2022, after confirming the lesion with the intravascular ultrasound (ivus) a percutaneous coronary intervention (pci) was performed to treat the proximal right coronary artery (rca).A 6fr guide catheter was introduced and the lesion was pre-dilated with an unspecified balloon.The xience skypoint stent was implanted and the procedure was completed.On (b)(6) 2022, the patient developed a stroke and was hospitalized.The patient subsequently recovered after the stroke.On (b)(6) 2023, the patient experienced an st elevated myocardial infarction (stemi).An unknown stent was implanted successfully in the left anterior descending (lad) artery but the patient developed thrombosis, residual emboli in the periphery and a cardiogenic shock with as (aortic stenosis).The patient was hospitalized but died on (b)(6) 2023.The physician stated the xience skypoint stent did not cause or contribute to the patient death.No additional information was provided.

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.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The reported patient effect of stroke are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 17186851
• MDR Text Key: 317725515
• Report Number: 2024168-2023-06630
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233395
• UDI-Public: 08717648233395
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

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
• Device Operator: Health Professional
• Device Model Number: 1804350-15
• Device Catalogue Number: 1804350-15
• Device Lot Number: 203224A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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; Disability
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 40 KG