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

Catalog Number 1500400-33

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

Patient Problems Non specific EKG/ECG Changes (1817); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Occlusion (1984)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation as the stent remains implanted in the patient.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 ischemia, occlusion and hypotension are listed in the xience sierra everolimus eluting coronary stent systems instructions for use 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.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 on (b)(6) 2019 one 4.0x33 mm xience sierra stent was implanted in the distal right coronary artery (rca).During the procedure there was no flow or slow flow in the distal rca after post dilatation.This was associated with st elevation and hypotension.Intravenous medications (aramine) and intravenous fluids were administered.Sodium nitroprusside and nitroglycerin were also administered medications.Although the condition resolved same day, the hospitalization was prolonged.The following day, on (b)(6) 2019 the patient had an elevated troponin t levels.No treatment was given and the condition is ongoing.The patient was discharged home on (b)(6) 2019.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: 10273435
• MDR Text Key: 201851388
• Report Number: 2024168-2020-05810
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: AS
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Catalogue Number: 1500400-33
• Device Lot Number: 9010941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73