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

Model Number	10622
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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.The target lesion was located in the mid right coronary artery (rca) with 95% stenosis and distal rcawith 75-80% stenosis.The physician pre-dilated the lesion with 1.5x12 semi-compliant (sc), 2.0x 15(sc), 3.0x 15(sc) and a 3.5 x15 non-compliant (nc) balloons.A guidezilla ii 6fr guide extension catheter was placed across the mid lesion for easier deployment.A 4.50 x 32 synergy drug-eluting stent was advanced for treatment.However, the front end of the stent was getting caught somewhere in the 6fr guide catheter.The physician fluroed and discovered that the stent was getting caught up at the helical collar of the guidezilla ii.The stent body was examined and observed that it had some damaged to it because of the collar interaction.The device was removed and the procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the mid right coronary artery (rca) with 95% stenosis and distal rcawith 75-80% stenosis.The physician pre-dilated the lesion with 1.5x12 semi-compliant (sc), 2.0x 15(sc), 3.0x 15(sc) and a 3.5 x15 non-compliant (nc) balloons.A 6fr gzii guide extension catheter was placed across the mid lesion for easier deployment.A 4.50 x 32 synergy drug-eluting stent was advanced for treatment.However, the front end of the stent was getting caught somewhere in the 6fr guide catheter.The physician fluroed and discovered that the stent was getting caught up at the helical collar of the gzii.The stent body was examined and observed that it had some damaged to it because of the collar interaction.The device was removed and the procedure was completed with a different device.There were no patient omplications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.50 x 32 mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent damage was found in the mid to distal stent region with stent struts in the distal region lifted and stent struts in the middle section found to be bunched.Reference photo 01).The undamaged 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 bumper tip identified no issues.A visual and tactile examination of the hypotube identified multiple hypotube kinks.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.

• 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: 11518643
• Report Number: 2134265-2021-02897
• Device Sequence Number: 19790341
• Product Code: NIQ
• UDI-Device Identifier: 08714729973393
• UDI-Public: 08714729973393
• Combination Product (Y/N): Y
• Initial Reporter State: MD
• 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
• Report Date (Section B): 04/15/2021

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: 08/06/2021
• Device Model Number: 10622
• Device Catalogue Number: 10622
• Device Lot Number: 0024295070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1