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

Model Number H7493911424250

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

Patient Problems Cardiomyopathy (1764); Death (1802); Thrombosis (2100)

Event Date 07/11/2014

Event Type  Death  

Event Description

Same case as mdr id: 2134265-2015-01438 (b)(6) it was reported that death occurred.In (b)(6) 2013, the patient presented due to unstable angina and the index procedure was performed.The target lesion was a de novo lesion located in the proximal left circumflex with 99% stenosis and was 60 mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50mm x 38.00mm promus element¿ plus stent and 2.50mm x 24.00mm promus element¿ plus stent.Following post-dilatation, residual stenosis was 0%.Two days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient expired due to end stage ischemic cardiomyopathy.Secondary causes were malnutrition and debility.No autopsy was performed.

Manufacturer Narrative

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

Event Description

Same case as mdr id: 2134265-2015-01438.It was further reported that stent thrombosis occurred.

Manufacturer Narrative

(b)(4).

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 4616557
• MDR Text Key: 17209469
• Report Number: 2134265-2015-01437
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• 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: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2013
• Device Model Number: H7493911424250
• Device Catalogue Number: 39114-2425
• Device Lot Number: 15511281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2012
• 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: 63 YR