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

Model Number	10605
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Reocclusion (1985); Restenosis (4576)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).Date of event: used date (b)(6) 2020 since specific event date was not provided.Initial reporter facility name: (b)(6) hospital.Initial reporter address 1: (b)(6) hospital.
Event or Problem Description
(b)(6) clinical study.It was reported that patient experienced angina and in-stent restenosis occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.On the next day, index procedure was performed.Target lesion #1 was located in proximal right coronary artery with 80% stenosis and was 24mm long with a reference vessel diameter of 4.5mm.Target lesion #1 was treated with pre-dilation and placement of a 4.5x 28mm synergy drug-eluting stent.Following post dilation, residual stenosis was 0%.Non target lesion was located in the right posterior descending artery (r-pda) and was treated with the placement of a 3.0x 28mm and a 2.25x 32mm synergy drug-eluting stents.On the same day, the subject was discharged on dual antiplatelet therapy.In 2020, in-stent restenosis was noted in the right pda.Unstable angina and electrocardiogram changes were found.The patient was sent to the cath lab and no further complications were reported.
Additional Manufacturer Narrative
B3: date of event: has been updated from (b)(6) 2020 to (b)(6) 2020.E1: initial reporter address 1 has been updated to (b)(6).A1: patient identifier: (b)(6).B3: date of event: used date (b)(6) 2020 since specific event date was not provided.E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 1: (b)(6) hospital.
Event or Problem Description
S2357 evolve 4.5-5.0 clinical study.It was reported that patient experienced angina and in-stent restenosis occurred.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.On the next day, index procedure was performed.Target lesion #1 was located in proximal right coronary artery with 80% stenosis and was 24mm long with a reference vessel diameter of 4.5mm.Target lesion #1 was treated with pre-dilation and placement of a 4.5x 28mm synergy drug-eluting stent.Following post dilation, residual stenosis was 0%.Non target lesion was located in the right posterior descending artery (r-pda) and was treated with the placement of a 3.0x 28mm and a 2.25x 32mm synergy drug-eluting stents.On the same day, the subject was discharged on dual antiplatelet therapy.In 2020, in-stent restenosis was noted in the right pda.Unstable angina and electrocardiogram changes were found.The patient was sent to the cath lab and no further complications were reported.In (b)(6) 2020, 209 days post index procedure, the subject visited the hospital with the complaints of unstable angina and subsequently electrocardiogram (ekg) was performed which revealed sinus rhythm, left axis deviation suggestive of left anterior fascicular block and nonspecific t abnormality.The 99% in-stent restenosis (isr) noted in the right pda was treated with pre-dilation using 2.5 mm apex balloon and 3.0 mm nc balloon followed by revascularization using 3.0 mm x 20 mm synergy drug eluting stent placement.Subsequently, post-dilation with 3.5 mm nc balloon was performed and the final residual stenosis was noted to be 0% with timi flow 3.On the same day, post procedure ecg revealed: sinus rhythm with poor r wave progression, borderline prolonged pr interval and right bundle branch block.On the following day, the subject was discharged from the hospital with clopidogrel.

• 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: 10870945
• Report Number: 2134265-2020-16026
• Device Sequence Number: 16781438
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup
• Report Date (Section B): 03/10/2022

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: 06/05/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0023937573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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: Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: White