MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10601
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
(b)(6) study.It was reported that in-stent restenosis occurred.In (b)(6) 2017, the subject had abnormal stress test and was referred for elective cardiac catheterization; on the same day index procedure was performed.The target lesion was located in the proximal left circumflex (lcx) with 90% stenosis and was 12mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 12mm study stent with 0% stenosis.On the next day the patient was discharge on dual antiplatelet therapy.In (b)(6) 2018, the patient was presented as a cardiology referral for further assessment prior to renal transplant.The patient was nuclear stress test did not reveal any localized ischemia; however, however tid was 1.3.The patient has complaints of non-severe shortness of breath with exertion.The patient was referred for left heart catheterization.On the same day, 90% in-stent restenosis in the proximal lcx and 70% stenosis in proximal lcx to mid lcx was treated with pre-dilatation and placement of 2 non-bsc drug eluting stents following which no residual stenosis and timi 3 flow was noted.The following day subject was discharged in stable condition.
Event or Problem Description
Evolve short dapt clinical study it was reported that in-stent restenosis occurred.In (b)(6) 2017, the subject had abnormal stress test and was referred for elective cardiac catheterization; on the same day index procedure was performed.The target lesion was located in the proximal left circumflex (lcx) with 90% stenosis and was 12mm long with a reference vessel diameter of 2.5mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 12mm study stent with 0% stenosis.On the next day the patient was discharge on dual antiplatelet therapy.In (b)(6) 2018, the patient was presented as a cardiology referral for further assessment prior to renal transplant.The patient was nuclear stress test did not reveal any localized ischemia; however, tid was 1.3.The patient has complaints of non-severe shortness of breath with exertion.The patient was referred for left heart catheterization.On the same day, 90% in-stent restenosis in the proximal lcx and 70% stenosis in proximal lcx to mid lcx was treated with pre-dilatation and placement of 2 non-bsc drug eluting stents following which no residual stenosis and timi 3 flow was noted.The following day subject was discharged in stable condition.It was further reported that in (b)(6) 2018, the patient was referred for left heart catheterization due to abnormal cardiovascular stress test.On the same day, coronary angiography revealed 40% stenosis proximal le anterior descending (lad) artery, 90% stenosis in ostial of 1st diagonal to 1st diagonal and 70-90% in-stent restenosis in proximal lcx target lesion and 40% stenosis of 1st obtuse marginal.
Additional Manufacturer Narrative
Device is a combination product.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/19/2018 11:15 am ct.The report number is being corrected from: 2134265-2018-64369 to: 2134265-2018-61434.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7920626
• Report Number: 2134265-2018-61434
• Device Sequence Number: 1347229
• Product Code: NIQ
• UDI-Device Identifier: 08714729840039
• UDI-Public: 08714729840039
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 01/05/2018
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0020154837
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 01/23/2019
• 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
• Patient Age: 54 YR