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

Model Number	10604
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2019
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 target lesion was located in a coronary artery.During an angioplasty procedure, a a 4.00 x 24 synergy drug-eluting stent was advanced for treatment.However, the stent was not deployed as it got fractured from a lesion within the vessel.The procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.During an angioplasty procedure, a a 4.00 x 24 synergy drug-eluting stent was advanced for treatment.However, the stent was not deployed as it got fractured from a lesion within the vessel.The procedure was completed with another of the same device.No patient complications nor injuries were reported.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and moderately calcified saphenous vein graft.The stent strut didn't exactly break in half but it kind of folded back on itself.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 4.00 x 24 mm stent delivery system was returned for analysis.An examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the 6th and 7th distal stent strut rows were noted to be lifted from their crimped position and pulled in a distal direction.The undamaged crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.The balloon was 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 tactile examination of the hypotube found multiple hypotube kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied to the delivery system.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.An examination (visual and via scope) found no issues with the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in a coronary artery.During an angioplasty procedure, a 4.00 x 24 synergy drug-eluting stent was advanced for treatment.However, the stent was not deployed as it got fractured from a lesion within the vessel.The procedure was completed with another of the same device.No patient complications nor injuries were reported.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and moderately calcified saphenous vein graft.The stent strut didn't exactly break in half but it kind of folded back on itself.

• 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: 8613236
• Report Number: 2134265-2019-05088
• Device Sequence Number: 11393742
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2019

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: 01/20/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0023258395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 06/25/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/04/2019; 07/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1