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

Model Number	1550225-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age, sex and weight: patient demographics were obtained from the (b)(6) 2020 baseline data.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2020, a mid-right coronary artery (rca) percutaneous intervention was performed.Two xience sierra stents were implanted in the mid rca without a device issue reported.On (b)(6) 2021, the patient was hospitalized with chest pain and medications were provided.Restenosis was observed in the distal portion of the 2.25x38mm xience sierra stent.As treatment, additional angioplasty was performed.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
Patient age, sex and weight: patient demographics were obtained from the (b)(6) 2020 baseline data.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2020, a mid-right coronary artery (rca) percutaneous intervention was performed.Two xience sierra stents were implanted in the mid rca without a device issue reported.On (b)(6) 2021, the patient was hospitalized with chest pain and medications were provided.Restenosis was observed in the distal portion of the 2.25x38mm xience sierra stent.As treatment, additional angioplasty was performed.No additional information was provided regarding this issue.
Additional 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 effects of angina and stenosis are listed in the xience sierra everolimus eluting coronary stent system instructions for use (ifu), 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 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.
Event or Problem Description
Subsequent to the previous medwatch report, the additional information was received: the chest pain started on (b)(6) 2021.On (b)(6) 2021, in-stent restenosis at the 2.25x38mm xience sierra stent distal edge was noted, treated with additional angioplasty and another oct run was performed.
Additional Manufacturer Narrative
B3, b5: updated.B3: date of event - updated b5: description of event.

• 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: 13054432
• Report Number: 2024168-2021-11980
• Device Sequence Number: 1661942
• Product Code: NIQ
• UDI-Device Identifier: 08717648227066
• UDI-Public: 08717648227066
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2021
• Device Model Number: 1550225-38
• Device Catalogue Number: 1550225-38
• Device Lot Number: 0031141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/28/2021; 01/10/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 12/29/2021; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• 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: XIENCE SIERRA STENT.; XIENCE SIERRA STENT.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White