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 H7493926020250

Device Problem Occlusion Within Device (1423)

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

Event Date 03/28/2018

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.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

(b)(6) clinical study.It was reported that angina and in-stent restenosis occurred.In (b)(6) 2018, clinical assessment indicated that the patient¿s qualifying condition was unstable angina and silent ischemia.Subsequently, coronary angiography and index procedure were performed.Target lesion #1 was located in the mid left anterior descending artery (lad) with 80% stenosis and was 13 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 16 mm study stent.Following post dilatation, the residual stenosis was 0%.Target lesion #2 was located in the proximal lad with 80% stenosis and was 21 mm long with a reference vessel diameter of 4.00 mm.The lesion was treated with pre-dilatation and placement of a 4.00 x 24 mm study stent.Following post dilatation, the residual stenosis was 0%.A 4.00 x 24 mm study stent covered 80% ostial stenosis in prox lad and also left main coronary artery (lmca).On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2018, the patient presented with complaints of progressive shortness of breath with exertion and chest tightness that started post stent placement.Electrocardiogram (ecg) revealed sinus rhythm with first degree av block and left bundle branch block.Twelve days later, 80% in-stent restenosis of the previously placed stent in mid lad was treated with pre-dilatation and placement of 2.50 x 8 mm synergy stent, following post dilation, residual stenosis was 0% with timi 3 flow.On the following day, the patient was discharged on dual antiplatelet therapy.

• 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: 7554159
• MDR Text Key: 109569678
• Report Number: 2134265-2018-04745
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• 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: 05/07/2018

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: 09/26/2018
• Device Model Number: H7493926020250
• Device Catalogue Number: 39260-2025
• Device Lot Number: 21215250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• 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: 79 YR