MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY TAXUS? ELEMENT?; CORONARY DRUG-ELUTING STENT

Model Number H7493902516300

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

Patient Problems Bradycardia (1751); Dyspnea (1816); Myocardial Infarction (1969); Pulmonary Edema (2020); ST Segment Depression (2487)

Event Date 07/14/2014

Event Type  Injury  

Event Description

(b)(4) clinical trial.Same case as mdr id: 2134265-2014-07398.It was reported that a myocardial infarction occurred.In (b)(6) 2011, the patient had a 100% stenosed lesion with a length of 3 mm and a reference vessel diameter of 16 mm located in the 1st obtuse marginal that was treated with pre-dilatation and placement of 3.0 mm x 16 mm and 3.50 mm x 20 mm taxus¿ element¿ stents, with 0 % residual stenosis.The patient was discharged the next day on aspirin and prasugrel.In (b)(6) 2014, the patient was diagnosed with cardiac decompensation and hyponatriumemia and was hospitalized on the same day.The patient was referred for problems with swallowing, walking and tendency to fall, cardiac insufficiency / bradycardia and was presented with ischemic symptoms, which was diagnosed as myocardial infarction.The patient also experienced renal insufficiency with benign nephrosclerosis and hyponatremia probably due to effects of diuretics during the same hospitalization.The neurological symptoms were most likely caused by hyponatremia.The patient was treated for bradycardia with atropine and diuretics were discontinued.The patient was treated with antibiotics for signs of inflammation and dyspnea.The patient was also diagnosed for pulmonary edema and was treated with non-invasive respiration with forced displacement using furosemide in the intensive care unit.Four days later, cardiac catheterization and transthoracic echocardiogram were performed which confirmed new st depression over the anterolateral wall.The patient also presented with ischemic symptoms and the subjects troponin value was noted to be elevated and the site reported an event of mi.The same day percutaneous coronary intervention (pci) to the left circumflex artery (lcx) was performed with an angioplasty balloon and placement of a drug-eluting stent.The patient was treated with mono embolex for atrial fibrillation and was transferred to intermediate care.Eight days later, the patient had acute loss of consciousness when deviated, vision deviated to right, pupils dilated and unresponsive to light.Cardiorespiratory resuscitation was performed for 25 minutes with no results.After this, ecg showed no cardiac activity and the subject was declared dead.The cause of death was due to a stroke and considered not related to the device.

Manufacturer Narrative

Age at time of event: 79-80 years.Date of birth: 1934.The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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).

Manufacturer Narrative

(b)(4).

Event Description

(b)(4) clinical trial same case as mdr id: 2134265-2014-07398.It was further reported that 1133 days post index procedure, the physician performed percutaneous coronary intervention (pci) to the proximal left circumflex artery (lcx) with balloon angioplasty and coronary artery bypass grafting (cabg).Saphenous vein graft (svg) to proximal lcx was performed to treat this event.

• Brand Name: TAXUS? ELEMENT?
• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4290504
• MDR Text Key: 22269123
• Report Number: 2134265-2014-07395
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P100023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2011
• Device Model Number: H7493902516300
• Device Catalogue Number: 39025-1630
• Device Lot Number: 13618030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2010
• 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): Required Intervention