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

Model Number 1550250-28

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

Patient Problems Dyspnea (1816); Stenosis (2263); Swelling/ Edema (4577)

Event Date 04/04/2022

Event Type  Injury  

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.The reported patient effects of stenosis and edema are listed in the xience sierra everolimus eluting coronary stent systems 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 subsequent 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

Patient id: (b)(6).It was reported that the procedure was performed on 10/02/2020 to treat a lesion in the proximal left anterior descending (lad) artery.A 2.75 x 15 mm xience sierra stent and a 2.5 x 28 mm xience sierra stent were implanted.On 04/04/2022, the patient was re-hospitalized with shortness of breath and lower extremity edema.Coronary catheterization was performed and noted 80% in-stent restenosis in the proximal and mid lad, in the 2.5 x 28 mm xience sierra stent and a previously implanted unspecified stent, and 90% stenosis in the circumflex (cx) artery.Angioplasty was performed to treat the in-stent restenosis in the 2.5 x 28 mm xience sierra stent.The event resolved on (b)(6) 2022.A staged procedure will be performed at a later date to treat the cx artery.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 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14212378
• MDR Text Key: 290104228
• Report Number: 2024168-2022-04504
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227127
• UDI-Public: 08717648227127
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2022

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: 01/05/2022
• Device Model Number: 1550250-28
• Device Catalogue Number: 1550250-28
• Device Lot Number: 0061841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White