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

Model Number H7493919938350

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

Patient Problems Angina (1710); Chest Pain (1776); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100)

Event Date 01/07/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mdr id 2134265-2017-00425.(b)(4) clinical study.It was reported that myocardial infarction, loss of flow to a vessel, angina and thrombosis occurred.In (b)(6) 2017, the patient presented to emergency department with complaints of 1-2 hour history of persistent chest pain.Electrocardiography (ecg) performed at emergency department revealed, bradycardia, ventricular rate of 30, third degree heart block and inferior st segment elevation.On the same day, cardiac enzymes were elevated consistent with protocol definition of spontaneous myocardial infarction (mi) (peak troponin: 0.158 ng/ml, uln: 0.1 ng/ml).An event of mi was reported.Patient was referred for cardiac catheterization and coronary angiography was performed.On the same day, occluded mid portion of the right coronary artery (rca) was treated with pre-dilatation and placement of two 3.50 x 38mm synergy biodegradable polymer drug-eluting stents in an overlapping manner.Following post-dilatation of both the stents, timi 3 flow was noted.Post intervention, angiography was performed which revealed cut off of the most distal segment of posterior descending artery (pda) due to embolized thrombus.Intervention of the chronically occluded left anterior descending (lad) stents was planned for a later date.On the second day, repeat lab investigations were performed which revealed elevated cardiac enzyme levels.On the next day, the patient had continued intermittent angina and was brought back for lad intervention.On the same day, entire length of previously placed stents (unknown manufacturer) in proximal and mid lad was treated with pre-dilatation and placement of two 2.75 x 38mm and one 2.25 x 38mm synergy biodegradable polymer drug eluting stents in an overlapping manner.Following post dilatation of all three stents, timi 3 flow was noted.Four days after, the patient was discharged on acetyl salicylic acid.On the (b)(6) the subject was diagnosed with acute on chronic congestive heart failure and st segment elevated myocardial infarction and was hospitalized.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that ten days after the patient was discharged, the patient was presented to the emergency department with complaints of acute sided chest pain with minimal shortness of breathing.The patient stated that this was similar to the prior chest pain.Ecg revealed non specific st and t wave abnormality.Cardiac enzymes were elevated consistent with protocol definition of spontaneous myocardial infarction (mi).Patient was diagnosed with acute on chronic congestive heart failure (chf), st elevation myocardial infarction (stemi), anemia and was hospitalized for the same.Serial troponins showed elevation.Coronary angiography was planned.The following day, coronary angiography was performed and revealed widely patent previously placed stents in proximal, mid and distal portions of right coronary artery; mild to moderate disease in posterior descending artery; patent posterolateral branch.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

It was further reported that stent thrombosis occurred to the two 2.75x38mm and one 2.25x38mm synergy¿ drug-eluting stents and not restenosis as what was previously reported.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2017, it was an unknown previously placed stent in rca that was treated with pre-dilatation and placement of two 3.50 x 38 mm synergy stents in an overlapping manner.Sixteen days after, in emergency, the patient had a mild elevation of troponin.The patient's brain natriuretic peptide (bnp) was found to be elevated and the patient was admitted to the hospital for congestive heart failure.

• 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: 6294953
• MDR Text Key: 66315137
• Report Number: 2134265-2017-00426
• 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,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H7493919938350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• 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): Required Intervention
• Patient Age: 75 YR