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

Model Number H7493902416400

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Occlusion (1984); Sweating (2444)

Event Date 02/27/2014

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2014-03050.(b)(4) study.It was reported that myocardial infarction, elevated cardiac enzyme, shortness of breath, nausea, excessive sweating, chest pain and restenosis occurred.In (b)(6) 2012, the patient was presented due to unstable angina and was referred for cardiac catheterization.The index procedure was performed.Target lesion #1 was an isr of unknown drug eluting stent located in the mid saphenous vein graft (svg) to right posterior descending artery (r-pda) with 90% stenosis and was 15 mm long with a reference vessel diameter of 4 mm.The lesion was treated with direct stent placement using 4.00 mm x 16 mm and 4.00 mm x 20 mm ion stents.Following post dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient was presented due to shortness of breath associated with sweating, nausea, sub sternal chest pain radiating towards neck and jaw and was hospitalized on the same day.It was observed that the patient experienced ischemic symptoms.The patient's cardiac enzymes were found to be elevated and myocardial infarction (mi) occurred.Additionally, electrocardiogram (ecg) revealed q wave mi.The 100% stenosis located in r-pda was treated with balloon angioplasty, with 0% residual stenosis.Eight days after the onset of symptoms, the events was considered resolved without residual effects and the patient was discharged on plavix and aspirin.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: 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).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported in (b)(6) 2014 a 100% totally occluded stent thrombosis was noted to the of the previously placed non study stents(4.5mm liberte stent, 4.0x12mm promus stent, 3.5x18mm promus, 4.00x18mm, promus stent, 4x16mm ion stent and 4x12mm ion stent) additionally the same day the patient was diagnosed with frontal lobe cva.

• 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 Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3846260
• MDR Text Key: 4615791
• Report Number: 2134265-2014-03052
• 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,Followup
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Model Number: H7493902416400
• Device Catalogue Number: 39024-1640
• Device Lot Number: 14835009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2011
• 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: 69 YR