MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926016250

Device Problem Occlusion Within Device (1423)

Patient Problems Angina (1710); Dyspnea (1816); Reocclusion (1985)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: the 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) clinical study.It was reported that stable angina and in-stent restenosis occurred.In (b)(6) 2017, clinical status assessment indicated the patient's qualifying condition as unstable angina and was patient was referred for cardiac catheterization.Subsequently, index procedure was performed.The target lesion was located in mid left anterior descending (lad) artery with 80% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of 2.50 mm x 16 mm study stent.Following post dilatation, residual stenosis was 0%.Two days after, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented for follow-up visit with the chief complaints of shortness of breath.The patient noted progression of symptoms despite augmented metoprolol therapy since last follow-up and electrocardiogram revealed normal sinus rhythm with left anterior fascicular block.The patient was referred for coronary angiography with possible percutaneous coronary intervention (pci) due to escalating anginal symptoms (with confirmed ischemia on stress echo) during the continued course of augmented medical therapy.In (b)(6) 2018, the patient was hospitalized for planned left heart catheterization and possible pci which revealed 90% in-stent restenosis (isr) of the study stent.The 90% isr in the mid lad was treated with pre-dilatation and placement of 2.50 x 12 mm non-bsc stent.Following post-dilatation, the residual stenosis was 0% with timi 3 flow.On the same day, 80% stenosis in the proximal lad was treated with pre-dilatation and placement of 2.50 x 08 mm non-bsc drug eluting stent with 0% residual stenosis and timi 3 flow.On the following day, the patient was discharged under stable condition on dual antiplatelet therapy with a referral to a cardiac rehabilitation.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 7491311
• MDR Text Key: 107502871
• Report Number: 2134265-2018-03844
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: 08714729840091
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• 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: 04/11/2018

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: 10/03/2017
• Device Model Number: H7493926016250
• Device Catalogue Number: 39260-1625
• Device Lot Number: 0019819923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR