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

Model Number	10621
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified right coronary artery.Following pre-dilatation with a 3.5x20 nc emerge balloon catheter, a 5.00 x 28mm synergy drug eluting stent was selected for use.However, upon removal from the hoop, it was noted that the distal stent edge and struts appeared to be damaged.The technician noted that the struts were sticking up and not smooth on the delivery system.The stent was not advanced into the guide catheter or loaded into wire and was replaced another of the same device.The procedure was completed and there were no patient complications reported.
Additional Manufacturer Narrative
E1- initial reporter address 1: (b)(6).Device evaluated by mfr.: synergy ii us mr 5.00 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts along the mid-section and distal end were lifted and pulled distally.The undamaged crimped stent outer diameter was measured using snap gauge 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 examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.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 stent damage occurred.The 80% stenosed target lesion was located in the non-tortuous and non-calcified right coronary artery.Following pre-dilatation with a 3.5x20 nc emerge balloon catheter, a 5.00 x 28mm synergy drug eluting stent was selected for use.However, upon removal from the hoop, it was noted that the distal stent edge and struts appeared to be damaged.The technician noted that the struts were sticking up and not smooth on the delivery system.The stent was not advanced into the guide catheter or loaded into wire and was replaced another of the same device.The procedure was completed and there were no patient complications 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: 11372986
• Report Number: 2134265-2021-02190
• Device Sequence Number: 19776495
• Product Code: NIQ
• UDI-Device Identifier: 08714729973461
• UDI-Public: 08714729973461
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 04/02/2021

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: 10/06/2021
• Device Model Number: 10621
• Device Catalogue Number: 10621
• Device Lot Number: 0024608761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1