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

Model Number H7493911420300

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

Patient Problems Chest Pain (1776); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Thrombosis (2100)

Event Date 01/01/2016

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

Promus element plus clinical study it was reported that the patient died.In (b)(6) 2012, the patient presented due to stable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed.Target lesion #1 was a de novo lesion located in the mid right coronary artery (rca) with 80% stenosis and was 20mm long with a reference vessel diameter of 3.0mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00mmx28mm promus element plus drug-eluting stent, with 0% residual stenosis.Target lesion #2 was a de novo lesion located in the proximal rca with 70% stenosis and was 16mm long with a reference vessel diameter of 3.0mm.Target lesion #2 was treated with direct stent placement using a 3.00mmx20mm promus element plus drug-eluting stent, with 0% residual stenosis.On the next day, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented per emergency medical services (ems) due to out of hospital cardiac arrest.In the morning, the patient's symptoms became worse and she pressed her life alert button.The patient was intubated, intravenous (iv) access was obtained and was placed on chest compression and epinephrine.After second dose of epinephrine, the patient had return of spontaneous circulation.After electrocardiogram (ekg) and chest x-ray, the patient again lost pulses and cardiopulmonary resuscitation (cpr) was resumed.The patient again had return of spontaneous circulation after repeat epinephrine dose.Subsequently, hypothermic protocol was initiated and improvement of vitals was noted.The patient was also placed on iv lasix for congestive heart failure (chf) exacerbation.Four days later, after discussion with the patient's family about the poor prognosis, it was decided to withdraw life support systems and subsequent comfort care measures were initiated.Subsequently, the patient expired.The primary cause of death is cardiac arrest.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that stent thrombosis occurred as per adjudication results.

• Brand Name: PROMUS ELEMENT¿ PLUS
• 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: 5410235
• MDR Text Key: 37464074
• Report Number: 2134265-2016-00341
• 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: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2012
• Device Model Number: H7493911420300
• Device Catalogue Number: 39114-2030
• Device Lot Number: 14885306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2011
• 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: 74 YR