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	H7493926008250
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombosis (2100); Pseudoaneurysm (2605)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a 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 root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
Same case as mdr id# 2134265-2017-07635.It was reported via user/facility medwatch# 5070686 that myocardial infarction and stent thrombosis occurred.The patient arrived at the emergency room (er) with st-segment elevation myocardial infarction (stemi).The patient was emergently transferred to the cardiac cath lab (ccl) and films revealed a 90% stenosed target lesion located in the right posterior descending artery (rpda).After pre-dilatation was performed with a 2.5 x 15 emerge mr balloon catheter, two synergy ii drug-eluting stents, 2.50 x 20 and 2.50 x 8, were deployed in overlapping manner with good results.Timi 3 flow and 0% residual stenosis were confirmed and the procedure was completed.The patient was discharged with instructions for acetylsalicylic acid (asa) 81mg, plavix 75mg, and coumadin 5mg, and to discontinue xarelto.The patient returned to the er with right femoral pseudoaneurysm which was treated medically.The patient was discharged with instructed to continue only asa and plavix at this time due to groin complications.The patient got confused at home regarding the medications and took no medications.The patient returned again to the er with stemi.The patient was taken emergently to the ccl where films revealed 100% thrombotic occlusion of the previously placed synergy ii drug-eluting stents in the rpda.As treatment, a 2.5 x 15 emerge mr balloon catheter was used to dilate the stents in overlapping inflations.Timi 3 flow was restored with 0% residual stenosis and the patient was discharged with instructions of asa 81mg and brilinta 90mg twice a day.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6736930
• Report Number: 2134265-2017-07429
• Device Sequence Number: 2014160
• Product Code: NIQ
• UDI-Device Identifier: 08714729839972
• UDI-Public: (01)08714729839972(17)20171122(10)20023915
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2017
• Device Model Number: H7493926008250
• Device Catalogue Number: 39260-0825
• Device Lot Number: 20023915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 07/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention