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

Model Number	1550250-38
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Date of Event	10/29/2021
Type of Reportable Event	Serious Injury
Additional 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.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of myocardial infarction and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as known patient effects of coronary stenting procedures.The investigation determined the reported patient-device incompatibility/difficult to deploy (wall apposition) and the subsequent treatment appears to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The additional xience sierra stent referenced and concomitant medical products is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the 99% stenosed, moderately calcified, moderately tortuous mid left anterior descending (lad) coronary artery.On (b)(6) 2021, a 2.5x38 mm and a 2.75x18 mm xience sierra stent were implanted.On (b)(6) 2021, the patient returned due to st elevated myocardial infarction (stemi) and then optical coherence tomography (oct) was performed.This revealed that the stents were under expanded and malposed as the physician did not adequately post dilate the overlap of the stents.Additionally there was in-stent thrombosis.Thrombectomy was performed and post dilatation was performed with a 3.25x15 mm nc trek balloon.Oct was again performed and showed 98% of expansion in the vessel and well apposed stent struts.There were no reported adverse patient sequela.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: 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: 12814854
• Report Number: 2024168-2021-10359
• Device Sequence Number: 5576005
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (Y/N): Y
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: 1550250-38
• Device Catalogue Number: 1550250-38
• Device Lot Number: 1042641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X18 MM XIENCE SIERRA STENT.
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Hispanic
• Patient Race: White