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

Model Number H7493919912300

Device Problem Occlusion Within Device (1423)

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

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

Device is 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 restenosis occurred.In (b)(6) 2013, the subject presented with stable angina (ccs classification: 2) and was referred for cardiac catheterization.Target lesion #1 was located in the proximal right coronary artery (rca) with 75% stenosis and was 10 mm long with a reference vessel diameter of 3.0 mm.Target lesion #1 was treated with pre-dilatation and placement of a 3.00 x 12 mm study stent.Residual stenosis was 0%.The subject was discharged on dual antiplatelet therapy.In (b)(6) 2018, the subject presented with complaints of chest pain.Cardiac enzymes were elevated consistent with spontaneous myocardial infarction.The subject was placed on medicated, hospitalized, and referred for cardiac catheterization.The subject was evaluated found to be a poor candidate for surgery so it was decided to perform staged percutaneous coronary intervention to the stenosis in rca and left main.The 80% stenosis in the distal portion of the previously placed study stent in the proximal rca was treated with pre dilatation and placement of a 2.25x15mm non-bsc drug eluting stent.Post procedure, the residual stenosis was 0% with timi 3 flow.The 90% stenosed left main coronary artery was treated with pre dilatation and placement of a 4.00x16mm synergy stent in the proximal left anterior descending artery extending back into the mid left main.Post dilatation, the residual stenosis was 0% with timi 3 flow.The subject was discharged in stable condition.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2018, the subject presented with chest tightness associated with shortness of breath and was given nitroglycerin and aspirin for the chest pain.

• 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: 7396931
• MDR Text Key: 104362351
• Report Number: 2134265-2018-02761
• 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
• Report Date: 03/13/2018

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: 09/16/2013
• Device Model Number: H7493919912300
• Device Lot Number: 15626574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/04/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/19/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR