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

Model Number H7493911424250

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

Patient Problems Death (1802); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Vomiting (2144); Cardiogenic Shock (2262); Diaphoresis (2452)

Event Date 07/11/2015

Event Type  Death  

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 most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as mdr id: 2134265-2015-05200.(b)(4).It was reported that myocardial infarction occurred and the patient died.In (b)(6) 2012, the patient presented due to unstable angina and was referred for cardiac catheterization.Subsequently index procedure was performed.Target lesion # 1 was a de novo lesion located in the proximal left anterior descending (lad) with 80% stenosis and was 30 mm long with a reference vessel diameter of 3.0 mm.Target lesion # 1 was treated with direct stent placement using a 2.50x24.00mm promus element⠐lus stent.Following post dilatation, residual stenosis was 0 %.Target lesion # 2 was a de novo lesion located in the mid lad with 80% stenosis and was 30 mm long with a reference vessel diameter of 3.0 mm.Target lesion # 2 was treated with direct stent placement using a 2.50x24.00mm promus element plus stent.Following post dilatation, residual stenosis was 0 %.Two days post-index procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2015, the patient presented emergently with complaints of acute non-radiating chest pain associated with diaphoresis, dyspnea, nausea and vomiting.The patient was placed on intravenous(iv) volume, endotracheal intubation and cardiopulmonary resuscitation(cpr) was initiated.The patient was treated with cardiogenic shock and despite aggressive medical therapy and prolonged cpr with multiple drugs, there was no pulse restoration.The patient remained in junctional bradycardia and sinus rhythm throughout the hospitalization and owing to his deteriorating clinical condition, critical care measures were initiated.The patient expired on the same day and the cause of death was acute mi.Autopsy was not performed.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient was scheduled for a cardiac catheterization, but the procedure was not performed.Hence, owing to the absence of a cardiac catheterization report, the patency of study stents is unknown.The patient was also noted to be in pulseless electrical activity.It was initially incorrectly reported that the patient was treated with cardiogenic shock when it should have been reported that the patient was in cardiogenic shock.

• 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 (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4992456
• MDR Text Key: 22581818
• Report Number: 2134265-2015-05201
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2013
• Device Model Number: H7493911424250
• Device Catalogue Number: 39114-2425
• Device Lot Number: 15418421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR