MAUDE Adverse Event Report: AV-TEMECULA-CT PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Dyspnea (1816); Fatigue (1849); Stenosis (2263)

Event Date 01/30/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2010, two promus stents were implanted in a lesion in the saphenous vein graft to the diagonal vessel.On (b)(6) 2014, the patient presented with chest pain, shortness of breath and fatigue.The patient was found to have restenosis and was referred for cardiac catheterization.On (b)(6) 2014, the event was considered resolved without residual effects and the patient was discharged the next day on aspirin and plasugrel.No additional information was provided.

Manufacturer Narrative

(b)(4).Incorrect anatomy.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The additional promus referenced is being filed under a separate medwatch report.You are receiving this mdr report from abbott vascular because boston scientific corporation distributes promus as its own brand labeling of abbott vasculars drug eluting stent in the us.

Manufacturer Narrative

(b)(4).The reported patient effects of unstable or stable angina pectoris, restenosis of the stented segment of the artery, dyspnea, and fatigue are listed in the promus everolimus eluting coronary stent system instructions for use (ifu) as known patient effects of coronary stenting procedures.Although 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 deficiency with respect to manufacturing, design or labeling.It was reported that the promus stents were implanted in a saphenous vein graft.It should be noted that the instructions for use (ifu) states: promus everolimus eluting coronary stent system (promus stent) is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported patient effects.

• Brand Name: PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3678325
• MDR Text Key: 4291339
• Report Number: 2024168-2014-01504
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR