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

Model Number H7493919912350

Device Problem Occlusion Within Device (1423)

Patient Problems Myocardial Infarction (1969); Reocclusion (1985)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

(b)(6) study.It was reported that myocardial infarction and in-stent restenosis (isr) occurred.In (b)(6) 2013, the subject presented with unstable angina (braunwald classification: iib) and was referred for cardiac catheterization.Prior to the procedure, the subject was found to have abnormal stress test or imaging stress test indicative of ischemia.Target lesion #1 was located in the mid right coronary artery (rca) with 95% stenosis and was 8 mm long with a reference vessel diameter of 3.5 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.50 x 12 mm study stent.Following post dilatation, the residual stenosis was 0%.On the same day, a 3.50x20mm study stent was implanted in the mid left anterior descending artery.The subject was discharged on dual antiplatelet therapy.In (b)(6) 2017, the subject presented to emergency department with the complaints of palpitations and was found to be diaphoretic.The subject stated that they were not having any recurrent chest pain which they had during their previous heart attack.Electrocardiogram (ekg) revealed sinus tachycardia with fusion complexes, inferior and anterior infarcts of undetermined age, st and t wave abnormality, consider lateral ischemia.Cardiac enzymes were elevated and the subject was diagnosed with non-st-elevation myocardial infarction (nstemi).The subject was hospitalized for further evaluation.Coronary angiography revealed 70% isr of the study stent in the rca.The patient was treated medically and discharged on dual antiplatelet therapy.

• 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: 7647930
• MDR Text Key: 112697665
• Report Number: 2134265-2018-05809
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2013
• Device Model Number: H7493919912350
• Device Lot Number: 15636701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR