MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE ION?; CORONARY DRUG-ELUTING STENT

Model Number H7493902416250

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

Patient Problems Cardiomyopathy (1764); Death (1802)

Event Date 04/20/2012

Event Type  Death  

Event Description

Same case as mdr id: 2134265-2014-02465.(b)(6) clinical study.It was reported that ischemic cardiomyopathy and patient death occurred.On (b)(6) 2012, the patient presented due to stable angina and was referred for cardiac catheterization.The index procedure was performed.The target lesion was a de novo, bifurcated lesion located in the 2nd obtuse marginal with 99% stenosis and was 14 mm long with a reference vessel diameter of 2.5 mm.Subsequently, the lesion was treated with pre-dilatation and placement of a 2.50 mm x 16 mm and 2.25 mm x 8 mm ion stent.Following post dilatation, residual stenosis was 0%.Seven days post procedure, the patient was discharged on aspirin and clopidogrel.On (b)(6) 2012, the patient was diagnosed with ischemic cardiomyopathy and was hospitalized.On the same day, the patient died.

Manufacturer Narrative

Device is a combination product.It is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: ION?
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• 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: 3796725
• MDR Text Key: 4366969
• Report Number: 2134265-2014-02462
• 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: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2013
• Device Model Number: H7493902416250
• Device Catalogue Number: 39024-1625
• Device Lot Number: 14831884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 63 YR