MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number 1550250-15

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

Patient Problem Angina (1710)

Event Date 07/09/2021

Event Type  Injury  

Event Description

Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2020, treating lesions in the mid right coronary artery (rca) and in the proximal left anterior descending (lad) artery.A 2.5 x 15 mm xience sierra stent was implanted in the rca and a 3.5 x 38 mm xience sierra stent was implanted in the lad.On (b)(6) 2021, the patient presented to the emergency department with chest pain, relieved with nitroglycerin.A coronary artery bypass graft (cabg) procedure was performed.Post procedure, the patient remained on intra-aortic balloon pump (iabp) for low ejection fraction.The patient was discharged to home on (b)(6) 2021.No additional information was provided.

Manufacturer Narrative

The stent remains in the 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 stent remains in the 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.

Event Description

Patient id: (b)(6).It was reported that the procedure was performed on (b)(6) 2020, treating lesions in the mid right coronary artery (rca) and in the proximal left anterior descending (lad) artery.A 2.5 x 15 mm xience sierra stent was implanted in the rca and a 3.5 x 38 mm xience sierra stent was implanted in the lad.On (b)(6) 2021, the patient presented to the emergency department with chest pain, relieved with nitroglycerin.A coronary artery bypass graft (cabg) procedure was performed.Post procedure, the patient remained on intra-aortic balloon pump (iabp) for low ejection fraction.The patient was discharged to home on (b)(6) 2021.No additional information was provided.

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.The reported patient effect of angina is listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT 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: 12913287
• MDR Text Key: 285224868
• Report Number: 2024168-2021-10950
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227097
• UDI-Public: 08717648227097
• 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: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 1550250-15
• Device Catalogue Number: 1550250-15
• Device Lot Number: 0010841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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): Required Intervention; Hospitalization; Disability
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White