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

Model Number H7493902416300

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); Thrombosis (2100); Diaphoresis (2452)

Event Date 12/27/2012

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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).

Event Description

Ion us coa clinical study.It was reported that acute myocardial infarction (ami) and restenosis occurred.In (b)(6) 2011, the patient was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was de novo lesion located in the 1st obtuse marginal (om) with 95% stenosis and was 12 mm long with a reference vessel diameter of 3 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00 mm x 16 mm ion us coa stent.Following post dilatation, residual stenosis was 0%.3 days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(4) 2012, the patients cardiac enzymes were found to be elevated and an event of mi was reported by the site.Subsequently, the patient was hospitalized on the same day.The following day, electrocardiogram (ecg) suggested unknown type of mi.It was observed that the patient experienced ischemic symptoms.The 100% restenosis of the stent located in 1st om was treated with balloon angioplasty and placement of drug eluting stent with 0% residual stenosis.The event was considered resolved without residual effects.4 days later, the patient was discharged.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that at the time of event, the patient presented with left hip fracture and coronary angiography was performed.During balloon angioplasty, an unspecified luge guide wire was advanced, but was unable to cross the lesion.Finally the lesion was crossed with non-bsc guide wire with the help of 2.5 x 8 mm emerge balloon and subsequently placement of a 3.0 x 16 mm promus element stent.In addition, a correction has been made to the previously reported restenosis in the proximal first obtuse marginal (om) to stent thrombosis of the study stent.

Manufacturer Narrative

Describe event or problem, patient code updated.Relevant tests/lab data corrected and updated.(b)(4).

Event Description

It was further reported that prior index procedure patient presented with cardiac arrest which was diagnosed as myocardial infarction (mi) and was referred for cardiac catheterization.Coronary angiography was performed.In (b)(6) 2012, the patient was treated with open reduction internal fixation (orif) of the left leg.Eleven days post procedure, the event was considered recovering/resolving and was discharged to rehabilitation unit.Subsequently, the patient developed acute chest pain with nausea and diaphoresis at rehabilitation unit and was transferred to intensive acute care.The 100% thrombosis of the study stent was also treated with thrombectomy and placement of 3.0 x 16 mm promus element stent, with 0% residual stenosis.On (b)(6) 2013, the patient was discharged on aspirin and clopidogrel.

• 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: 3610529
• MDR Text Key: 18768031
• Report Number: 2134265-2014-00402
• 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,Followup
• Report Date: 01/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2013
• Device Model Number: H7493902416300
• Device Catalogue Number: 39024-1630
• Device Lot Number: 14635980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2011
• 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: 88 YR