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

Catalog Number 1009544-18B

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

Patient Problems Angina (1710); Dyspnea (1816); Myocardial Infarction (1969); Dizziness (2194); Stenosis (2263)

Event Date 03/30/2012

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, the subject suffered a myocardial infarction (mi); however, it is unknown if the mi is related to the promus stents deployed on (b)(6) 2011.No treatment was performed.On (b)(6) 2014, the subject presented with complaints of refractory chest pain discomfort with shortness of breath and dizziness for which no immediate treatment was performed; however, was scheduled for a left heart catheterization on (b)(6) 2014.The subject visited the facility for the planned intervention, was diagnosed with cardiac chest pain and rehospitalized.Coronary angiography revealed a subtotal occlusion in the obtuse marginal with a 99% instent restenosis of the previously deployed 2.25x18 mm and 2.5x23 mm promus stents.The restenosis was treated with balloon angioplasty resulting in a 0% stenosis.The event was considered to be resolved without residual effects and the subject was discharged on the same day.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The reported patient effects of angina, myocardial infarction, and restenosis, as listed in the promus everolimus eluting coronary stent system instructions for use (ifu) are known patient effects that may be associated with the used of the device.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.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.The 2.5x23mm promus is being filed under a separate medwatch report.

• 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: 4249138
• MDR Text Key: 5045792
• Report Number: 2024168-2014-07444
• 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
• Report Date: 10/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1009544-18B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2014
• 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
• Treatment: STENT: 2.5X23MM PROMUS
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 58 YR