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

Model Number	10606
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
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 target lesion was located in the non-tortuous and mildly calcified left circumflex artery.A 2.50 x 32 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and damage was noted on the actual stent struts.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.50 x 32 mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found that on the most distal strut rows and most proximal stent strut rows, the stent struts were lifted and opening in a 360-degree dimension.The undamaged section of the crimped stent od (outer diameter) was measured and the result is within maximum crimped stent profile measurement.This type of damage is consistent with positive pressure being applied to the stent.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 tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force that could have been applied on the delivery system during preparation.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner extrusion shaft found no issues along the shaft polymer extrusion.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 the non-tortuous and mildly calcified left circumflex artery.A 2.50 x 32 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was removed and damage was noted on the actual stent struts.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: 9832943
• Report Number: 2134265-2020-03297
• Device Sequence Number: 16867968
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: 08714729840336
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 04/09/2020

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: 05/08/2020
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0022131275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1