MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING

Model Number UNK717

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

Patient Problems Congestive Heart Failure (1783); Death (1802); Edema (1820); Weakness (2145)

Event Date 09/21/2015

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-01494.(b)(4) clinical study it was reported that the patient died.In (b)(6) 2013, the patient presented due to silent ischemia and coronary angiography was performed.Target lesion #1 was located in the distal left circumflex (lcx) artery with 100% stenosis and was 30.00mm long with a reference vessel diameter of 3.00mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00x32.00mm promus element plus drug-eluting stent.Following post-dilatation, residual stenosis was 0%.Target lesion #2 was located in the proximal lcx with 80% stenosis and was 20.00mm long with a reference vessel diameter of 3.50mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00x20.00mm promus element plus drug-eluting stent.Following post-dilatation, residual stenosis was 10%.On the same day, the patient was discharged on aspirin and prasugrel.In (b)(6) 2015, the patient was admitted due to hyponatremia and despite multiple attempts with medications, the patient's sodium did not correct.Twelve days after, the patient was discharged.Since the discharge, the patient was having weakness, increased weight gain and leg swelling.In (b)(6) 2015, the patient was admitted to the emergency department due to increased weakness, acute on chronic systolic congestive heart failure (chf) and worsening renal failure.The patient was hypotensive and the worsening kidney function was in setting of fluid overload and more chf.The patient had no urine output since over 24 hours prior to admission.The patient was also noted to have severe renal artery stenosis (ras) which would make the patient more sensitive to fluid shifts.The patient was started on dobutamine drip to aid diuresis and was admitted to the intensive care unit (icu).The patient's oxygen requirement increased and thus the patient was placed on continuous positive airway pressure (cpap).Despite these attempts, the patient's blood pressure did not improve and oxygen saturation dropped.The patient was getting more obtunded and after consultation with cardiologist, renal intensivist and discussion with family members, comfort care measures were placed.The following day, the patient expired.The preliminary cause of death was end stage heart failure with organ failures.

• Brand Name: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5503136
• MDR Text Key: 40386302
• Report Number: 2134265-2016-01493
• 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
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK717
• Device Lot Number: BATCH_UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 68 YR