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

Model Number	10601
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
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 a coronary artery.A 3.00 x 12mm synergy ii drug-eluting stent was advanced but was not able to cross the lesion.After removal, the stent struts was noted to be askew.The procedure was completed with another synergy stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.Lot number updated from 0024606454 to 0024221120.Expiration date updated from 10/06/2021 to 07/28/2021.Device manufacture date updated from 10/07/2019 to 07/29/2019.Device evaluated by mfr: an examination (visual and via scope) of the crimped stent found stent damage.Stent struts from the mid stent region were noted to be lifted from their crimped position and pulled distally.The undamaged crimped stent od (outer diameter) was measured using snap gauge and the results were within max 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 signs of distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.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.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.A 3.00 x 12mm synergy ii drug-eluting stent was advanced but was not able to cross the lesion.After removal, the stent struts was noted to be askew.The procedure was completed with another synergy stent.There were no patient complications 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: 10414486
• Report Number: 2134265-2020-11212
• Device Sequence Number: 11365240
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/01/2020

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: 07/28/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024221120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1