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

Model Number	10606
Medical Device Problem Codes	Failure to Advance (2524); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 32 synergy drug-eluting stent was advanced for treatment.However, during advancing, resistance was felt and it was noted that the proximal end of the stent was damaged.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 3.00 x 32 mm stent delivery system was returned for analysis with the customer's guidewire inserted and inside the customer's guidecatheter.The stent could not be withdrawn proximally into guide due to the extent of the stent damage.To remove it from the guidecatheter, the hypotube was cut at the strain relief.An examination of the crimped stent found stent damage.Stent struts from the proximal region of the stent were noted to be lifted from their crimped position and bunched distally.The undamaged crimped stent was measured using snap gauge and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The proximal balloon cone as well as the mid to proximal balloon region was exposed and crimp marking could be noted on the balloon wall, but the balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.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 stent damage occurred.A 3.00 x 32 synergy drug-eluting stent was advanced for treatment.However, during advancing, resistance was felt and it was noted that the proximal end of the stent was damaged.The device was completely removed and the procedure was completed with another of the same device.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
• MDR Report Key: 11795081
• Report Number: 2134265-2021-06005
• Device Sequence Number: 3972258
• Product Code: NIQ
• UDI-Device Identifier: 08714729840350
• UDI-Public: 08714729840350
• Combination Product (Y/N): Y
• Initial Reporter State: NE
• 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
• Report Date (Section B): 06/14/2021

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: 06/22/2022
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0025654672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR