MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE TAXUS® LIBERTÉ®; CORONARY DRUG-ELUTING STENT

Model Number H7493893616400

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

Patient Problems Abdominal Pain (1685); Death (1802); Edema (1820); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Pain (1994)

Event Date 02/13/2013

Event Type  Death  

Event Description

Same case as mdr id# 2134265-2014-05184.(b)(4).It was reported that myocardial infarction (mi) and patient death occurred.In (b)(6) 2010, the patient presented due to elevated blood sugar, abdominal pain and altered mental status.The patient was diagnosed with unstable angina and cardiac catheterization was recommended.Subsequently, coronary angiography and index procedure were performed.Target lesion #1 was located in the mid right coronary artery (rca) with 85% stenosis and was 18 mm long with a reference vessel diameter of 3.50 mm.The lesion was treated with direct placement using a 24 x 3.50mm taxus® liberté® stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was located in the distal left circumflex (lcx) artery with 75% stenosis and was 12 mm long with a reference vessel diameter of 4.00 mm.The lesion was treated with direct placement using a 16 x 4.00mm taxus® liberté® stent.Following post-dilation with a non-bsc balloon, small perforation to the distal lcx artery was noted and was treated with placement of two non-bsc covered stents, resulting in 0% residual stenosis with sealing of perforation.Five days post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2013, the patient presented with complaints of abdominal pain, back pain and was noted to have elevated white blood cells (wbcs), non-healing wound, edema and weight gain.The patient was diagnosed with infected graft site and was hospitalized and treated with medications.At the time of the event, the patient was on aspirin and clopidogrel.The study drug per protocol was last taken in (b)(6) 2011.The event was considered resolved without residual effects and the patient was discharged on aspirin and clopidogrel the following day.Five days after hospitalization, the patient expired at 7:00 am due to acute mi.Autopsy was not performed.Per death certificate, the primary cause of death was acute mi and secondary causes were coronary artery disease, hypertension and diabetes.

Manufacturer Narrative

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

• Brand Name: TAXUS® LIBERTÉ®
• 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: 4058769
• MDR Text Key: 4903107
• Report Number: 2134265-2014-05185
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060008
• 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: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2011
• Device Model Number: H7493893616400
• Device Catalogue Number: 38936-1640
• Device Lot Number: 13367974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR