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

Catalog Number 1550225-15

Device Problems Expiration Date Error (2528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263); Diaphoresis (2452)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed on (b)(6) 2020, to treat a lesion in the left main coronary artery.The patient had a xience sierra stent was implanted successfully with no tissues.However, the patient was re-hospitalized on (b)(6) 2020 for fatigue, hypotension, and dyspnea.Medication was administered.Elevated troponin and a myocardial infarction (mi) were diagnosed.A heparin was administered.Angiography revealed in-stent stenosis was observed in the implanted stent.An unspecified stent was implanted as treatment within the xience sierra stent implant.The patient is stable.No additional information was provided.

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 part and lot numbers were not provided.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.The reported patient effects of hypotension, myocardial infarction and stenosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previous medwatch report, the additional information was received: on(b)(6)2019 , the patient had a myocardial infarction (mi) and was taken to the emergency department.The patient was taken for a percutaneous coronary intervention and a xience sierra stent was implanted with no complications.The patient was discharged home a few days later.It was discovered by the patient's family that the implanted xience sierra stent was part of a recall due to an expiration date labeling issue.On (b)(6)2019 , a left ventricular thrombus was reported, treated with medications.On (b)(6)2020 , the patient was hospitalized for another mi.Imaging was performed with no change noted.Reportedly, the event was due to the stent.Reportedly, the patient blacks out but doesn't faint and starts pouring sweat.The patient has been referred to a vascular surgeon to evaluate him for thrombus removal and a stent bypass graft.No additional information was provided regarding this issue.

Manufacturer Narrative

The investigation is not yet complete.A follow-up report will be generated, reporting additional, relevant information.A field safety corrective action was taken regarding one lot of the xience sierra rx everolimus eluting coronary stent system.Devices from this lot were shipped with a 36-month labeled expiration date instead of the 12-month expiration date that is currently approved in the united states.A4, b3, d6,.

Manufacturer Narrative

The device remained implanted and 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 hypotension, myocardial infarction, thrombosis and stenosis 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 effect(s), and the relationship to the product, if any, cannot be determined.However, the 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.Additional reported information provided the implanted xience sierra part number as 2.25x15 (1550225-15).This device number is not included in the field safety corrective.

Event Description

Subsequent to the previous report, the additional information was obtained: on 02/19/2019, a 2.25x15 (1550225-15) xience sierra stent had been implanted.This device number was not part of the field safety corrective action.

• 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
• MDR Report Key: 9829734
• MDR Text Key: 183294312
• Report Number: 2024168-2020-02399
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1550225-15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2370-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 83