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

Model Number 1804325-23

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

Patient Problems Myocardial Infarction (1969); Sepsis (2067)

Event Date 03/21/2022

Event Type  Injury  

Event Description

It was reported that the patient has a history of st elevated myocardial infarction (stemi) and on (b)(6) 2022 a 3.5x23 mm xience skypoint stent was implanted.On (b)(6) 2022 the patient was re-hospitalized due to an acute myocardial infarction and unspecified sepsis.Medication was provided and no additional patient effects were reported.No additional information was provided.

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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.Based on the information reviewed, there is no indication of a product quality issue.The reported patient effects of sepsis and myocardial infarction are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) 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.

Event Description

It was reported that the patient has a history of st elevated myocardial infarction (stemi) and on (b)(6) 2022 a 3.5x23 mm xience skypoint stent was implanted.On (b)(6) 2022 the patient was re-hospitalized due to an acute myocardial infarction and unspecified sepsis.Medication was provided and no additional patient effects were reported.Subsequent to the initially filed report, the following information was provided: the patient was discharged from the initial procedure on (b)(6) 2022 and was discharged from readmission on (b)(6) 2022.No additional treatment was performed other than the medication provided.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: 15043509
• MDR Text Key: 296077047
• Report Number: 2024168-2022-07824
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233333
• UDI-Public: 08717648233333
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

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: 09/02/2023
• Device Model Number: 1804325-23
• Device Catalogue Number: 1804325-23
• Device Lot Number: 1083141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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): Disability; Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 93 KG