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

Model Number	9336
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/19/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
(b)(6) clinical study.It was reported that cardiac arrest occurred and patient died.In (b)(6) 2013, the patient's qualifying condition was unstable angina.The patient was found to have elevated biomarkers which evidences indicative of ischemia and was referred for cardiac catheterization which resulted to 80% stenosis in the proximal obtuse marginal (ob) and index procedure was performed.Target lesion was located in the 1st ob marginal with 70% stenosis and was 22mm long with a reference vessel diameter of 2.25mm.Target lesion was treated with pre-dilatation and placement of a 2.5x28mm study stent and the residual stenosis was found to be 1%.Two days post procedure, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, while diving the patient went into cra (cardiac respiratory arrest).He was given basic cardiopulmonary resuscitation (cpr) by lifeguards for approximately 8 minutes.Emergency medical services continued with advanced cpr, first heart rate was pulseless electrical activity.Orotracheal intubation was conducted with orotracheal tube conducted with orotracheal tube number 7 with frova anterior glotic intubation.After 24 min of cpr the patient regained a pulse without acute repolarization abnormalities.The patient was then brought to the emergency department where his condition was stable.He was breathing symmetrically across both "hemithoracec".The patient was transferred to intensive care unit (icu) and in deep coma with a glasgow coma scale of 3 points with no brain stem reflexes, the subject was also found to have deterioration of renal function.On the fourth day of progression, the neurological examination showed no changes so the treatment was suspended and the patient expired.The documented cause of death was reported as cardiac arrest.

• Brand Name: PROMUS ELEMENT PLUS
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8155570
• Report Number: 2134265-2018-63840
• Device Sequence Number: 18895097
• Product Code: NIQ
• UDI-Device Identifier: 08714729807797
• UDI-Public: 08714729807797
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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: 10/14/2013
• Device Model Number: 9336
• Device Catalogue Number: 9336
• Device Lot Number: 15683476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR