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

Model Number	10605
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Angina (1710); Obstruction/Occlusion (2422)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) study.It was reported that chronic occlusion of diagonal branch and stent under expansion at ostium occurred.In (b)(6) 2020, the index procedure was performed and in (b)(6) 2020, the subject indicated the qualifying condition unstable angina.Hence, the subject was referred for cardiac catheterization.Target lesion 1 was located in saphenous vein graft (svg) to obtuse maginal (om) with 90% stenosis and was 15 mm long with a reference vessel diameter of 4.5 mm.Target lesion 1 was treated with direct placement of a 4.50 mm x 32 mm study stent with residual stenosis was 0%.On the same day, subject was discharged on aspirin.Three weeks and four days later, despite improvement of symptoms, subject continued to experience angina due to severe stenosis noted in svg to diagonal artery.Hence, percutaneous coronary intervention (pci) of left anterior descending (lad) artery- diagonal artery were considered.Left main coronary artery (lmca), proximal lad, mid lad, distal lad, 1st diagonal artery were treated with percutaneous transluminal coronary angioplasty (ptca) and drug-eluting stent (des) stenting using 2.50 mm x 24 mm synergy stent and 3.00 mm x 28 mm synergy stent in an overlapping fashion extending from lmca to diagonal artery.In (b)(6) 2021, subject continued to experience progressive angina despite being on optimal medical therapy.Subsequently, subject underwent selective dual coronary angiography and left heart catherization which revealed chronically occluded diagonal branch with severe disease of svg to the diagonal artery (3.00 mm x 28 mm synergy stent).On the same day, during the treatment of lad, under expansion of 3.00 mm x 28 mm synergy stent at the ostium of the diagonal branch was noted, which was treated with high pressure nc balloon but was unable to achieve full expansion.Hence, the lesion was further treated with laser atherectomy followed by intravascular lithotripsy using 3.0 shockwave balloon.After ensuring successful expansion of the lesion, it was stented with 2.5 mm x 32 mm synergy des with overlap of prior stents in lad.Stents were post dilated with appropriately sized nc balloons at high pressure.The 100% stenosis was noted to be reduced to 0% with change in pre timi flow from 0 to post timi flow 3.No other complications of dissection, loss of side branch, embolization after intervention were observed.
Additional Manufacturer Narrative
Patient identifier: (b)(6).

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13020173
• Report Number: 2134265-2021-15924
• Device Sequence Number: 14653465
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): Y
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024171593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: White