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

Model Number H7493919912300

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Cardiomyopathy (1764); Chest Pain (1776); Dyspnea (1816); Reocclusion (1985); Dizziness (2194)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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

Same case as mdr id 2134265-2017-05750.(b)(6) clinical study.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was myocardial infarction (mi) with unstable angina.Prior to procedure, the patient was found to have elevated biomarkers indicative of ischemia and the patient was referred for cardiac catheterization.On the same day, the index procedure and coronary angiography were performed.The target lesion was located in the mid left anterior descending (lad) artery with 95% stenosis and was 10mm long with a reference vessel diameter of 3.0mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 12mm study stent.Following post-dilation, residual stenosis was 0%.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2016, the patient was hospitalized due to dyspnea and dizziness and the patient was referred for angiography.There were multiple proximal to mid lad stents and the patency of the study stent is unknown.Isr was present in mid lad and it was treated with placement of a 2.75 x 20mm promus element plus drug-eluting stent.The most distal lad stent has a discrete 95% stenosis.The patient was considered for surgical intervention coronary artery bypass graft (cabg surgery) but refused to proceed with the surgery.Nineteen days after, the patient was presented due to stable angina and severe ischemic cardiomyopathy.Based on the patient's persistent symptoms, severe cardiomyopathy, and high-grade lad stenosis, the patient was referred for percutaneous coronary intervention (pci).The 95% stenosis in mid lad was treated with pre-dilatation and by a 3.0 x 12mm non-bsc bioabsorbable scaffold system.Following post-dilatation, no residual stenosis and timi 3 flow was noted.The patient was discharged on dual antiplatelet therapy on the same day.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient was diagnosed with multivessel coronary artery disease with extensive left anterior descending (lad) artery in-stent restenosis including focal area up to 95% in the mid lad.The patient was considered for surgical intervention based on the patient's multivessel coronary artery disease and lvef of approximately 20%.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that following post-dilatation during the index procedure, residual stenosis was 0% with no evidence of dissection, distal embolization, or loss of side branch.In (b)(6) 2016, the patient presented with complaints of progressive exertional dyspnea and dizziness.The patient had ischemic cardiomyopathy and premature coronary artery disease.The patient is also having recurrent vague chest pain and shortness of breath.Subsequently, the patient was recommended for cardiac catheterization to assess for progression of disease or restenosis.

• 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: 6601039
• MDR Text Key: 76284232
• Report Number: 2134265-2017-05749
• 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,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• 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: H7493919912300
• Device Lot Number: 15626574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2012
• 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): Required Intervention
• Patient Age: 60 YR