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

Model Number	10607
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in a mildly tortuous and moderate to severely calcified vessel.A 4.00 x 38 synergy drug-eluting stent was selected for use but was unable to advance into lesion even after rotablation with a 1.75mm burr.The stent struts were damaged and the procedure was completed with another synergy stent.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.00 x 38mm stent delivery system was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts in the most proximal strut row were lifted and pulled in a distal direction.The undamaged 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 and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found issues with bunching noted in the distal inner extrusion 80mm proximal to distal end of tip.A 0.014" guidewire, verified and loaded successfully through the distal end of the tip to a depth of 80mm where it met an obstruction in the form of polymer extrusion bunching.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The 80% stenosed target lesion was located in a mildly tortuous and moderate to severely calcified vessel.A 4.00 x 38 synergy drug-eluting stent was selected for use but was unable to advance into lesion even after rotablation with a 1.75mm burr.The stent struts were damaged and the procedure was completed with another synergy stent.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: 10313884
• Report Number: 2134265-2020-09086
• Device Sequence Number: 19635708
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024666504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1