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

Model Number	10620
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.4.50 x 28mm and 4.50 x 24mm synergy ii drug-eluting stents were unable to pass through a 6f guidezilla guide catheter and was damaged.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.50 x 24mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts along the distal end were lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result is 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 examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.4.50 x 28mm and 4.50 x 24mm synergy ii drug-eluting stents were unable to pass through a 6f guidezilla guide catheter and was damaged.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.50 x 24mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts along the distal end were lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result is 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 examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product analysis.H6 - evaluation conclusion codes updated from adverse event related to procedure d1002 to failure to follow instructions d1101.
Event or Problem Description
It was reported that stent damage occurred.4.50 x 28mm and 4.50 x 24mm synergy ii drug-eluting stents were unable to pass through a 6f guidezilla guide catheter and was damaged.No patient complications were reported.

• 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: 11235542
• Report Number: 2134265-2021-00825
• Device Sequence Number: 14545805
• Product Code: NIQ
• UDI-Device Identifier: 08714729973379
• UDI-Public: 08714729973379
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• 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): 03/16/2021

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: 10/15/2021
• Device Model Number: 10620
• Device Catalogue Number: 10620
• Device Lot Number: 0024656628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/17/2021; 02/25/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/23/2021; 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1