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

Model Number H7493919928350

Device Problem Occlusion Within Device (1423)

Patient Problems Chest Pain (1776); Headache (1880); Reocclusion (1985); Anxiety (2328); Diaphoresis (2452)

Event Date 11/15/2016

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 med watch will be filed.(b)(4).

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis (isr) and chest pain occurred.In (b)(6) 2013, clinical assessment indicated the patient¿s qualifying condition as stable angina.Subsequently, the patient was referred for cardiac catheterization and index procedure was performed.The target lesion was located in the mid left anterior descending (lad) artery with 75% stenosis and was 20 mm long with a reference vessel diameter of 3.5 mm.The target lesion was treated with pre-dilatation and placement of a 3.50 x 28 mm study stent with residual stenosis was 0%.On the same day, the patient was discharge on dual antiplatelet therapy.In (b)(6) 2016, the patient presented with complaints of chest pain associated with diaphoresis, headaches and anxiety.The patient was referred for selective angiography and percutaneous coronary intervention.The 80% stenosis in the proximal lad also involving the proximal edge of the previously deployed stent in the mid lad and was treated with placement of 3.5 x 12 mm promus premier drug eluting stent.Post stent deployment, the residual stenosis was 0% with timi 3 flow.On the following day, the patient was discharged on dual antiplatelet medication.

Manufacturer Narrative

(b)(6) 2016.(b)(4).

Event Description

It was further reported that in (b)(6) 2016, the patient was diagnosed with venous reflux.Electrocardiogram revealed sinus rhythm, left axis-anterior fasicular block, inferior-lateral infarct, and anterolateral st-elevation.The patient took sublingual nitroglycerin several times a weeks for chest discomfort.

• 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: 6241572
• MDR Text Key: 64487585
• Report Number: 2134265-2016-12455
• 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: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2013
• Device Model Number: H7493919928350
• Device Lot Number: 15697628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2012
• 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: 64 YR