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 High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969)

Event Date 10/28/2021

Event Type  Injury  

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.The reported patient effects of myocardial infarction and hypertension 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.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that on 10/19/2021 the patient had a 3.50x23 mm xience skypoint stent implanted.On (b)(6) 2021 and (b)(6) 2021, the patient was re-hospitalized due to hypertensive heart and acute myocardial infarction.The type of treatment was assistance respiratory ventilation and there was no adverse patient sequela.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: 14022489
• MDR Text Key: 288678341
• Report Number: 2024168-2022-03613
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233418
• UDI-Public: 08717648233418
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2022

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 Expiration Date: 03/22/2023
• Device Model Number: 1804350-23
• Device Catalogue Number: 1804350-23
• Device Lot Number: 1031642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2021
• 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; Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 124 KG