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

Model Number H7493911632220

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

Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Renal Failure (2041); Shock (2072); Respiratory Failure (2484)

Event Date 02/07/2014

Event Type  Death  

Event Description

Same case as mdr id: 2134265-2015-00514; 2134265-2015-00515 and 2134265-2015-00517.(b)(4).It was reported that acute respiratory failure and death occurred.In october 2012, the patient was referred for cardiac catheterization.Subsequently, coronary angiography the index procedure were performed.The target lesion # 1 was a de novo lesion located in the right posterior descending artery (r-pda) with 80% stenosis and was 10 mm long with a reference vessel diameter of 2.25 mm.The lesion was treated with direct placement of a 2.25 mm x 12 mm promus element¿ plus stent, resulting to 0% residual stenosis.Target lesion # 2 was a de novo lesion located in the mid right coronary artery (rca) with 80% stenosis and was 10 mm long with a reference vessel diameter of 2.25 mm.The lesion was treated with direct placement of a 2.25 mm x 12 mm promus element¿ plus stent, resulting to 0% residual stenosis.The target lesion # 3 was a de novo lesion located in the proximal rca with 90% stenosis and was 28 mm long with a reference vessel diameter of 2.25 mm.The lesion was treated with direct placement of a 2.25 mm x 32 mm promus element¿ plus stent, resulting to 0% residual stenosis.Target lesion # 4 was a de novo lesion located in the 1st obtuse marginal (om) with 80% stenosis and was 10 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with direct placement of a 2.50 mm x 12 mm promus element¿ plus stent, resulting to 0% residual stenosis.One day post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2014, the patient presented emergently with acute respiratory failure, diabetic ketoacidosis, shock, non st elevation myocardial infarction (nstemi) (status post cardiac arrest and resuscitation en route), and renal failure.The patient had not taken insulin for 2 days and the patient was already intubated for assisted ventilation on arrival to emergency room (er).Computed tomography (ct) scan of the head revealed cerebral edema but no acute process.Patient's prognosis was poor.The patient was then treated aggressively with fluids and medications, including advanced cardiac life support (acls) measures, until family produced documentation of legal power of attorney/healthcare proxy.On the following day, after verification of patient's wishes, aggressive therapy was discontinued in favor of comfort care measures only.Subsequently, the patient expired.Death certificate is not available and autopsy was not performed.The primary cause of death was acute respiratory failure.

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).

• Brand Name: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4487467
• MDR Text Key: 5328434
• Report Number: 2134265-2015-00516
• 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
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: H7493911632220
• Device Catalogue Number: 39116-3222
• Device Lot Number: 14940929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2012
• 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: 55 YR