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

Model Number H7493919938300

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985); ST Segment Elevation (2059)

Event Date 01/05/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the device was not returned for analysis.A review of the manufacturing documentation found that all devices shipped from the batch conformed to the preventive measures / current controls.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

(b)(6).It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2013, clinical status assessment indicated the patient's qualifying condition was unstable angina.Cardiac catheterization was recommended.Subsequently, the index procedure was performed.The target lesion was located from proximal left anterior descending (lad) artery extending up to mid lad with 90% stenosis and was 24mm long with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of a 38x3.00mm study stent and residual stenosis was 0% (timi flow 3).In (b)(6) 2013, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient was diagnosed with acute myocardial infarction/non st elevation mi (nstemi) and was hospitalized on the same day.The troponin i levels were elevated to 0.094 ng/ml.Cardiac catheterization revealed high grade isr with moderate stenosis at the proximal portion of the study stent.On the same day, isr in mid lad was treated with placement of two drug-eluting stents (des) (3.0x15mm and 3.25x12mm) with the residual stenosis was 0% (timi flow 3).Additionally, on the same day, percutaneous coronary intervention (pci) of proximal right coronary artery was treated with placement of 3.0x28mm des with the residual stenosis was 0% (timi flow 3).The following day, the patient was discharged from the hospital.

• 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: 6888971
• MDR Text Key: 87176247
• Report Number: 2134265-2017-09199
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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
• Report Date: 08/29/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2013
• Device Model Number: H7493919938300
• Device Lot Number: 15714695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR