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

Model Number	10605
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 28mm synergy drug-eluting stent was selected for use.However, it was noted that the stent struts were bent.The physician opened another stent which delivered and deployed successfully.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 28mm synergy drug-eluting stent was selected for use.However, it was noted that the stent struts were bent.The physician opened another stent which delivered and deployed successfully.No patient complications were reported.It was further reported that the stent would not cross the lesion and the bent struts were noticed after it was removed.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.50 x 28 mm stent delivery system was returned for analysis.A visual examination of the stent identified that the crimped stent was damaged on the mid-section of the stent with struts lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.The balloon cones were 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 microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks on several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.A 2.50 x 28mm synergy drug-eluting stent was selected for use.However, it was noted that the stent struts were bent.The physician opened another stent which delivered and deployed successfully.No patient complications were reported.It was further reported that the stent would not cross the lesion and the bent struts were noticed after it was removed.

• 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: 11564176
• Report Number: 2134265-2021-03845
• Device Sequence Number: 14577132
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2021

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: 10/27/2022
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0026312980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 05/17/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/06/2021; 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1