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

Model Number 1804350-23

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)

Event Date 03/12/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, an emergency percutaneous coronary intervention (pci) procedure was performed on a patient with acute myocardial infarction who was taken from a different hospital.Complete occlusion on right coronary artery (rca), left circumflex (lcx), and acute coronary syndrome (acs) due to the heavy stenosis on left anterior descending (lad) artery were noted.Thrombectomy was performed on the lad.After intravascular ultrasound (ivus) and plain old balloon angioplasty (poba), pre-dilatation was performed on the proximal lad.The 3.5x23 mm xience skypoint stent delivery system (sds) and 3.0x33mm xience skypoint sds were deployed at the proximal lad and the mid lad.Calcification in the distal left circumflex (lcx) with 100% stenosis, lesion length 35mm, lesion radius 2.5mm and tortuosity and heavy calcification in the proximal lcx with 100% stenosis, lesion length 10mm, lesion radius 2.75mm were noted.A non-abbott guide wire and guiding catheter were inserted into lcx.After pre-dilatation by a non-abbott balloon catheter at lcx, a non-abbott stent was deployed at the proximal lcx and distal lcx, without post-dilatation.The stent expansion was confirmed by imaging.The patient was taken into critical care unit (ccu).On (b)(6) 2022, sudden changes occurred in the patient¿s condition and went into cardiac arrest.Occlusion occurred from ostia of lad and lcx due to thrombosis and was confirmed by imaging.Under intra-aortic balloon pump (iabp), the lesions were dilated with a balloon catheter, but the patient died due to a fall in blood pressure.According to the physician who performed the procedure, the cause of thrombosis was unknown.Medications were administered.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of thrombosis and hypotension are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic 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; however, the reported treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional skypoint device is being filed under a separate medwatch report number.

• 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: 14215060
• MDR Text Key: 290149826
• Report Number: 2024168-2022-04538
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: 08717648233418
• 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: Other
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1804350-23
• Device Catalogue Number: 1804350-23
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 3.0X33MM XIENCE SKYPOINT SDS
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male