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

Model Number	H7493911412350
Medical Device Problem Codes	Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Thrombosis (2100)
Date of Event	01/22/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
Age at time of event: (b)(6) old.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 or Problem Description
Same case as mdr id: 2134265-2017-04007.(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, the patient presented due to unstable angina and was diagnosed with myocardial infarction (mi).Subsequently, coronary angiography and index procedure were performed.The target lesion #1 was a de novo lesion located in proximal left anterior descending (lad) artery with 80% stenosis and was 10mm long with a reference vessel diameter of 3.5mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.50x12mm promus element¿ plus drug-eluting stent.Following post-dilatation, the residual stenosis was 0%.The target lesion #2 was a de novo lesion located in distal right coronary artery (rca) with 100% stenosis and was 26mm long with a reference vessel diameter of 3.0mm.Target lesion #2 was treated with pre-dilatation and placement of a 3.00x28mm promus element¿ plus drug-eluting stent.Following post-dilatation, the residual stenosis was 0%.On the following day, the patient was discharged on aspirin and prasugrel.In (b)(6) 2017, the patient was found unresponsive by the family in the home.Subsequently, the patient was brought to emergency medical service.Upon arrival, the patient was noted to have agonal breathing and thereafter, the patient went into cardiac arrest.Then, the patient was intubated and provided with advanced cardiac life support (acls) protocol with cardiopulmonary resuscitation (cpr).Physical examination revealed, patient unresponsive, endotracheal tube (ett) in place, pupils fixed and dilated, no spontaneous heart sounds, no spontaneous lung sounds and extremities cold to touch.Later, cardiac ultrasound was performed which revealed no cardiac motion.As per emergency medical services (ems), the total down time without rosc was 20 plus minutes, so the physician decided to stop further resuscitative efforts.Then the patient's family was made aware of the patient's poor prognosis condition and following discussions, the patient was switched to "do not resuscitate" (dnr) status.On the same day, the patient expired.The primary cause of death is "cardiac arrest" and the underlying cause for cardiac arrest was "metastatic prostate cancer".Per death certificate, the immediate cause of death is "metastatic prostate cancer" and "coronary artery disease".The other contributing factors were "hypertension" and "diabetes".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was further reported that adjudication indicates stent thrombosis occurred.

• Brand Name: PROMUS ELEMENT¿ PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6483128
• Report Number: 2134265-2017-04042
• Device Sequence Number: 1198628
• Product Code: NIQ
• UDI-Device Identifier: 08714729808008
• UDI-Public: (01)08714729808008(17)20131205(10)0015779636
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2013
• Device Model Number: H7493911412350
• Device Catalogue Number: 39114-1235
• Device Lot Number: 0015779636
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death