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

Model Number	10609
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a markerband issue was encountered.A 2.50 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the markers (90cm and 100cm) on the shaft were switched.The stent was implanted and the procedure completed.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
The device was not returned for analysis, however a photo was received which showed the shaft of the device and confirmed the 100 cm and 90 cm white hot stamp markers were switched in position.Two markers were located at 90 cm instead of one, and one marker was located at 100 cm instead of two.
Event or Problem Description
It was reported that a markerband issue was encountered.A 2.50 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the markers (90cm and 100cm) on the shaft were switched.The procedure was completed and there were no patient complications nor injuries reported.
Additional Manufacturer Narrative
The synergy ii us otw 2.50 x 12 mm stent delivery system was returned for analysis without the stent.The device was returned without the stent as it was deployed without issues at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted.Balloon folds are partially open, and crimp markings are visible on the exposed balloon wall.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube found no issues.The two hot stamps markers on the hypotube shaft were located at 90 cm proximal to tip instead of one, and one hot stamp marker was located at 100 cm from tip instead of two.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.
Event or Problem Description
It was reported that a markerband issue was encountered.A 2.50 x 12 synergy drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the markers (90cm and 100cm) on the shaft were switched.The procedure was completed and there were no patient complications nor injuries reported.

• 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: 12554069
• Report Number: 2134265-2021-12037
• Device Sequence Number: 983184
• Product Code: NIQ
• UDI-Device Identifier: 08714729840510
• UDI-Public: 08714729840510
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2021

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: 04/13/2023
• Device Model Number: 10609
• Device Catalogue Number: 10609
• Device Lot Number: 0027190992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 12/06/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/21/2021; 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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
• Patient Sex: Unknown