MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number H7493952816300

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

Patient Problems Atherosclerosis (1728); Atrial Fibrillation (1729); Cardiopulmonary Arrest (1765); Congestive Heart Failure (1783); Death (1802); Pneumonia (2011); Respiratory Distress (2045); Respiratory Failure (2484)

Event Date 06/23/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).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: 2134265-2016-00731.(b)(4).It was reported that the patient died.In (b)(6) 2015, clinical assessment indicated that the patient's qualifying condition was unstable angina.This was a staged procedure.In the prior month, the patient had undergone rotablation and stent placement of the left anterior descending (lad) artery.The target lesion was a de novo lesion with severe calcification located in the proximal circumflex (cx) artery.There was 85% stenosis.The lesion length was 24mm, with a reference vessel diameter was 3.0mm.The target lesion was pre-dilated with a 2.75mm balloon at 20 atmospheres and insertion of two overlapping promus premier everolimus-eluting platinum chromium coronary stents: 2.75x12mm (mid-cx) and 3.00x16mm (ostial cx).Rotational atherectomy (rotablation) was performed with 1.75 burr 5 times at small runs.Balloon angioplasty with a 2.75x20mm noncompliant balloon was also employed.Post dilatation with 2.5mm balloon at 16 atmospheres was performed with the same stent balloon at the site of the bridging of the two stents.There was 0% residual stenosis.The patient was kept overnight with the sheath in place, and with a heparin drip at 300 units/hr.A day post procedure, the patient was discharged on aspirin and clopidogrel.At discharge, cardizem was discontinued and amiodarone 200mg twice daily was begun.Other discharge medications included acetaminophen, furosemide 20mg four times daily, synthroid, vesicare, and pantoprazole.Two days post procedure, the patient was brought to the hospital via ambulance for severe respiratory distress and ultimate respiratory failure.Initially, bi-level positive airway pressure (bipap) was initiated, but the patient soon required intubation due to acute pulmonary edema.The patient was transferred to intensive care and a critical care consultation was obtained.On presentation, the patient was found to be in atrial fibrillation with a rapid ventricular rate.A computed tomography (ct) angiogram of the chest revealed a possible acute bilateral pneumonia.This was treated with iv broad-spectrum antibiotics.An infectious disease consultation was obtained.A thoracentesis was performed.The patient's respiratory status gradually improved.The patient was then transferred out of intensive care.Post extubation, iv total parenteral nutrition (central line) was administered due to the risk of aspiration.On an unreported date, the patient's respiratory status again decompensated.The patient was transferred back to intensive care and was re-intubated.The patient's overall prognosis was assessed as poor.Post consultation with family, the patient was terminally extubated.Eleven days post index procedure, per the hospital discharge summary, the patient died.The death certificate listed the causes of death as cardiopulmonary arrest, acute respiratory failure, and pneumonia.Other contributing conditions included atherosclerotic cardiovascular disease and congestive heart failure.

• Brand Name: PROMUS PREMIER¿
• 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: 5434740
• MDR Text Key: 38203887
• Report Number: 2134265-2016-00732
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2016
• Device Model Number: H7493952816300
• Device Catalogue Number: 39528-1630
• Device Lot Number: 17718302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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: 79 YR