MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number UNK776

Device Problems Occlusion Within Device (1423); Activation, Positioning or Separation Problem (2906)

Patient Problems Bradycardia (1751); Chest Pain (1776); Cardiac Enzyme Elevation (1838); Ischemia (1942); Myocardial Infarction (1969); Reocclusion (1985); Diaphoresis (2452)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is anticipated procedural complication as the reported event is due to a known physiological effect of the procedure noted within the product directions for use (dfu) and/or device labeling.(b)(4).

Event Description

(b)(6) study.Same case as mfr report#: 2134265-2016-10130, 2134265-2016-10131.It was reported that following a coronary artery drug eluting stenting treatment procedure, the patient had in-stent restenosis (isr) and myocardial infarction (mi).In (b)(6) 2015, the patient was diagnosed with st elevation mi and was hospitalized.75% stenosis in the mid right coronary artery (mid rca) was treated with balloon angioplasty and placement of a 3.50x38mm promus element plus stent with 0% residual stenosis.The event was considered as resolved and the patient was discharged on aspirin and ticagrelor.5 days later, the patient was admitted due to non-compliant with the anti-platelet therapy for the past 5 days and subsequently, the patient was diagnosed with inferior st elevation mi.The 100% stenosis in proximal rca was treated with balloon angioplasty and placement of a 3.50x38mm promus element plus stent from proximal to mid rca with 0% residual stenosis.The event was considered as resolved and the patient was discharged on aspirin and ticagrelor.In (b)(6) 2016, the patient was diagnosed with progression of coronary artery disease.70% isr in the mid rca was treated with pre-dilatation and placement of a 3.00x28mm synergy ii stent, with 0% residual stenosis following post-dilation.The event was considered as resolved and the patient was discharged on aspirin and clopidogrel.In (b)(6) 2016, the patient presented to the emergency department (ed) with the complaint of substernal chest pain radiating to back between shoulder blades.In ed labs were significant with an elevated troponin and ecg showed non st elevation or t wave inversions.During examination, the patient was also noted to have bradycardia.Cardiac enzyme was noted to be elevated and mi event was reported.90% isr of the three stents in mid rca was identified and treated with pre-dilatation and balloon angioplasty with 0% residual stenosis and timi 3 flow.Two days later, the event was considered as resolved and the patient was discharged.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient presented to hospital with chest pain.He stated the pain was relatively sharp and it radiated to his left arm and back.He had associated diaphoresis.He had some relief in pain intensity after administration of nitroglycerine and morphine.Troponin i values were found to be elevated and an event of non st elevation myocardial infarction was reported.Cardiology was consulted for management recommendations and the patient was referred for cardiac catheterization.Three days later, the 80% stenosis in mid rca was treated with balloon angioplasty.Post procedure residual stenosis was 20% with timi 3 flow.The next day the event was considered resolved and the patient was discharged.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the 80% in-stent restenosis in mid rca was treated by aggressively dilating the stent using a 4x12mm nc emerge mr balloon catheter.But the balloon failed to optimally expand the stents.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6098375
• MDR Text Key: 59718871
• Report Number: 2134265-2016-10132
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR