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

Model Number H7493911408300

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Ischemia (1942); Myocardial Infarction (1969); Occlusion (1984); Septic Shock (2068); Vomiting (2144)

Event Date 05/01/2016

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

(b)(6) clinical study.It was reported that restenosis and death occurred.In (b)(6) 2013, the patient's qualifying condition was unstable angina and was referred for cardiac catheterization.Subsequently, the index procedure was performed on the same day.The target lesion was located in the mid left anterior descending artery (lad) with (b)(4) stenosis and was 10mm long with a reference vessel diameter of 3.0mm.The lesion was treated with pre-dilatation and placement of a 3.0x8.00mm study stent with (b)(4) residual stenosis.Two days post procedure, the patient was discharged on dual antiplatelet therapy.In april 2016, the patient was presented to emergency department due to dyspnea and lower abdominal pain.The patient also had vomiting and constant diarrhea.Subsequently, the patient was hospitalized on the same day.Cardiac enzymes were found to be elevated and subsequently cardiac catheterization was recommended.Coronary angiography was performed and revealed a (b)(4) in-stent restenosis (isr) of study stent and sub total occlusion in the central third (past the previously inserted stent).Twelve days later, the (b)(4) isr in the mid lad was treated with balloon angioplasty and placement of 3.0x15.00mm non-bsc bare metal stent with (b)(4) residual stenosis.The days after post procedure, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient was presented to emergency room (er) following resuscitation at home.Subsequently, the patient was admitted to intensive care and intubation was initiated.Medical therapy was initiated.Patient coronary angiography revealed patent stent.Electrocardiogram (ecg) demonstrated pardee waves in v4-v5-v6, suggestive of acute myocardial infarction (ami) with takotsubo cardiomyopathy suspected on the basis of extreme metabolic acidosis.Severe lactic acidosis with recurrence of an intestinal infraction.Palliative approach was commenced.However, the patient expired in he intensive care unit due to "takotsubo syndrome".

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient was also diagnosed with septic shock due to pyelonephritis with e.Coli resulting in metabolic acidosis with a high anion gap.

• 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: 5805885
• MDR Text Key: 49901054
• Report Number: 2134265-2016-06371
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2013
• Device Model Number: H7493911408300
• Device Catalogue Number: 39114-0830
• Device Lot Number: 15604496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2012
• 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: 72 YR