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

Model Number UNK758

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 11/11/2016

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.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The cause of the reported difficulties could not be determined.(b)(4).

Event Description

Pe plus clinical study.Same case as mfr report#: 2134265-2017-09662.It was reported that myocardial infarction (mi), cardiac arrest and death occurred.In (b)(6) 2012, the patient presented due to stable angina (ccs classification: 1) and was referred for cardiac catheterization.The de novo target lesion was located in the proximal left anterior descending artery (prox lad) with 90% stenosis and was 20 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00x12mm promos element plus drug-eluting stent.Following post dilatation, residual stenosis was 0%.Additionally, the 80% proximal stenosis in the 1st diagonal branch (dx1) was treated with balloon angioplasty, resulting in 40% residual stenosis.The patient was discharged on aspirin and clopidogrel the next day.In(b)(6) 2015, the patient presented with the symptoms of chest pain and subsequently diagnosed as worsening coronary artery disease and was hospitalized on the same day.The 99% stenosis located in proximal lad was treated with balloon angioplasty and placement of 3.0 x 16 promus premier des with no residual stenosis.In (b)(6) 2016, the patient presented to the emergency department with chest pain and was in marked distress.The cardiac enzymes were noted to be elevated and site reported an event of mi.In the meantime, the patient became unresponsive which required intubation and cardiopulmonary resuscitation (cpr).The patient was given medications in response to the same, however the attempts were unsuccessful.Later on the patient developed bradycardia and then finally cardiac collapse in route to the hospital.The patient expired due to cardiac collapse.The cause of death was 'cardiac arrest '.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that adjudication indicates stent thrombosis.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6930372
• MDR Text Key: 88703658
• Report Number: 2134265-2017-09663
• 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: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 50 YR