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

Model Number	10606
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that the stent was not visible under fluoroscopy.The target lesion was located in a coronary artery.A 2.50 x 32mm synergy ii drug-eluting stent was advanced for treatment; however, it was noted that the device was not visible under the x-ray.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that the stent was not visible under fluoroscopy.The target lesion was located in a coronary artery.A 2.50 x 32mm synergy ii drug-eluting stent was advanced for treatment; however, it was noted that the device was not visible under the x-ray.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.Device evaluated by mfr: synergy ii us mr 2.50 x 32mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The balloon was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.An examination (visual and via scope) of the tip identified tip damage.The device was placed inside 2 transparent plastic pouches and placed under the fluoroscopy machine in the galway r&d sim use laboratory to check if the device could be seen.The stent and 2 markerbands could be seen under fluoroscopy.A photo was taken of the display screen to record the result.No other issues were noted during analysis.
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 12/17/2018 06:00 pm ct.The report number is being corrected from: 2134265-2018-64450 to: 2134265-2018-62889.

• 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: 8074658
• Report Number: 2134265-2018-62889
• Device Sequence Number: 16735376
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0022217397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1