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

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

Patient Problems Angina (1710); Dyspnea (1816); Myocardial Infarction (1969); Respiratory Distress (2045); Thrombosis (2100)

Event Date 07/15/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, 1211 days post index procedure the subject presented with complaints of chest pain, shortness of breath, cough and respiratory distress and was hospitalized on the same day.An echocardiogram revealed sinus tachycardia and st elevation in ii, iii, avf, v3 leads.Troponin and cardiac enzymes were found to be elevated.The subject was diagnosed with acute st elevation myocardial infarction and cardiac catheterization was recommended.Coronary angiography revealed a patent stented segment in the proximal segment with no significant restenotic lesion beneath the thrombus which was noted in mid segment.100% totally occluded (thrombus) and in-stent restenosis of the study stents and the 2.5 x 28 mm promus stent deployed in proximal rca and extending till mid was observed which was treated with aspiration thrombectomy and balloon angioplasty, with 0% residual stenosis.On (b)(6) 2014, the event was considered to be resolved without residual effects and the subject was discharged on the same day on aspirin and prasugrel.No additional information was provided.

Manufacturer Narrative

(b)(4).Angina, dyspnea, myocardial infarction and thrombosis are listed in the promus everolimus eluting coronary stent systems 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.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.

• 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: 4295274
• MDR Text Key: 5271182
• Report Number: 2024168-2014-07906
• 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,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• 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
• Date Manufacturer Received: 11/12/2014
• 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: 72 YR