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

Model Number 1550250-23

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 05/31/2022

Event Type  Injury  

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 angina and stenosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported angina and stenosis, and the relationship to the product, if any, cannot be determined.The subsequent treatment(s) of unexpected medical intervention (additional therapy/non-surgical 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; therefore, no product-related corrective action will be implemented in this case.

Event Description

Patient id: (b)(6).It was reported that a 2.5x23 mm xience sierra stent was implanted in the mid left anterior descending (lad) coronary artery on (b)(6) 2020.The patient experienced angina on (b)(6) 2021.On (b)(6) 2022, during a follow up, 75% stenosis was noted in the proximal lad; however, no in-stent restenosis was noted in the xience sierra stent in the mid lad.On (b)(6) 2022, elective intervention was performed to treat the proximal lad and a 3.0x23 mm xience skypoint stent was implanted.The patient was discharged from the hospital the following day.According to the physician¿s opinion, the event is not related to the study as it is a treatment for de novo lesion occurring in the natural history; however, it is unknown if the restenosis was +/- 5 mm from the target lesion.No additional information was provided.

• 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 (P031); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15789269
• MDR Text Key: 303571887
• Report Number: 2024168-2022-11541
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227110
• UDI-Public: 08717648227110
• 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,Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1550250-23
• Device Catalogue Number: 1550250-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 79 KG