MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10618
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier: (b)(6).
Event or Problem Description
(b)(6) registry.It was reported that stent incomplete apposition occurred.In (b)(6) 2020, the subject presented with coronary artery disease.Angiography was performed which revealed chronic total occlusion of mid coronary artery with left to right collaterals and 80% focal stenosis in proximal left anterior descending artery (lad).In addition, echocardiogram revealed severely reduced left ventricular stroke volume with severely low flow gradient aortic stenosis.Target lesion 1 was located in proximal lad with 80% lesion and was 14 mm long with a distal vessel diameter of 4.5 mm.In (b)(6) 2020, the 80% stenosed, 4.5mm x 14mm target lesion in the proximal lad was treated with pre-dilation using a 3.0 x 12 nc balloon, followed by placement of a 4.5 x 16 synergy drug eluting stent.The stent was post dilated with a 4.5 x 8 mm nc balloon.Intravenous ultrasound (ivus) revealed mild malposition in the distal portion of the stent and the stent was post dilated again with a 5.0 x 8mm nc balloon throughout the stent with residual stenosis noted to be 0%.Completion angiography showed an excellent result without apparent complication.Five days later, subject was discharged on dual antiplatelet therapy.
Event or Problem Description
Evolve_lv_xlv registry: it was reported that stent incomplete apposition occurred.In (b)(6) 2020, the subject presented with coronary artery disease.Angiography was performed which revealed chronic total occlusion of mid coronary artery with left to right collaterals and 80% focal stenosis in proximal left anterior descending artery (lad).In addition, echocardiogram revealed severely reduced left ventricular stroke volume with severely low flow gradient aortic stenosis.Target lesion 1 was located in proximal lad with 80% lesion and was 14 mm long with a distal vessel diameter of 4.5 mm.In (b)(6) 2020, the 80% stenosed, 4.5mm x 14mm target lesion in the proximal lad was treated with pre-dilation using a 3.0 x 12 nc balloon, followed by placement of a 4.5 x 16 synergy drug eluting stent.The stent was post dilated with a 4.5 x 8 mm nc balloon.Intravenous ultrasound (ivus) revealed mild malapposition in the distal portion of the stent and the stent was post dilated again with a 5.0 x 8mm nc balloon throughout the stent with residual stenosis noted to be 0%.Completion angiography showed an excellent result without apparent complication.Five days later, subject was discharged on dual antiplatelet therapy.
Additional Manufacturer Narrative
A1 patient identifier: (b)(6).H1type of reportable event and h6 patient codes: corrected.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11845722
• Report Number: 2134265-2021-06424
• Device Sequence Number: 11656623
• Product Code: NIQ
• UDI-Device Identifier: 08714729973355
• UDI-Public: 08714729973355
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

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: 10/13/2021
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0024655945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: Other
• Patient Age: 76 YR