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

Model Number	10606
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 4.00x32mm synergy ii drug-eluting stent was advanced to treat the lesion.However, it was noted that the shaft broke.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 4.00x32mm synergy ii drug-eluting stent was advanced to treat the lesion.However, it was noted that the shaft broke.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy ii us mr 4.00 x 32 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent was measured 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 and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the hypotube found a hypotube break at 205 mm distal to the distal end of the strain relief.Hypotube kinks were also noted along several locations of the hypotube shaft.This type of damage is consistent with excessive force that might have been applied on the delivery system.A visual and tactile examination of the outer extrusion and mid-shaft section and visual examination of the inner extrusion found no issues with the extrusion shaft.

• 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: 10516381
• Report Number: 2134265-2020-11524
• Device Sequence Number: 16755643
• Product Code: NIQ
• UDI-Device Identifier: 08714729840374
• UDI-Public: 08714729840374
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/22/2020

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: 04/02/2021
• Device Model Number: 10606
• Device Catalogue Number: 10606
• Device Lot Number: 0023621203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1