MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT

Model Number UNK692

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Fatigue (1849); Headache (1880); Reocclusion (1985)

Event Date 04/24/2014

Event Type  Injury  

Event Description

(b)(4) study.It was reported that angina, dyspnea and in-stent restenosis (isr) occurred.In (b)(6) 2011, the patient presented for a 2 week follow-up visit post percutaneous coronary intervention (pci).Fifteen days later, a planned cardiac catheterization and coronary angiography was done subsequently, the index procedure was performed.The target lesion was a de novo lesion located in the proximal right coronary artery (rca) with 80% stenosis and was 15 mm long with a reference vessel diameter of 2.75 mm.It was treated with pre-dilatation and placement of a 2.75 x 32 mm taxus liberte stent resulting in 0% residual stenosis.In addition, 80% stenosis in proximal left circumflex lcx (non-target lesion) was treated with placement of 2.50 x 16 mm ion stent.Post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented with chest pain and dyspnea on exertion associated with shortness of breath, fatigue and headache.Five days after, the patient was diagnosed with cardiac angina and was hospitalized on the same day.At the time of event, the patient was only on aspirin, the study drug per protocol was last taken five days prior to admission and other antiplatelet medication was never taken during this study.Cardiac catheterization was recommended.Coronary angiography was performed and revealed 80% isr of previously placed 2.50 x 16 mm ion study stent in proximal lcx and 70% stenosis in proximal rca to distal rca.The lesions were treated with coronary artery bypass graft (cabg) x 4, from saphenous vein graft (svg) to distal rca, svg to obtuse marginal(om), svg to 1st diagonal (d1) and left internal mammary artery (lima) to left anterior descending (lad) artery.The event was considered not recovered/not resolved.Five days post procedure, the patient was discharged on aspirin and prasugrel.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the complaint device was not returned for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

• Brand Name: ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3889002
• MDR Text Key: 4651497
• Report Number: 2134265-2014-03505
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2014
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR