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

Model Number	10601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 12mm synergy ii drug-eluting stent was advanced for treatment; however, it was noted that the main body was fractured more than 15cm from the hub, resulting in two separate pieces of the stent delivery system (sds).It was noted under fluoroscopy that the distal end of the stent never exited the guiding catheter and so the entire fractured sds was removed together with the guide catheter.The procedure was completed with another of the same device.No patient harm nor complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 4.00 x 12mm synergy ii drug-eluting stent was advanced for treatment; however, it was noted that the main body was fractured more than 15cm from the hub, resulting in two separate pieces of the stent delivery system (sds).It was noted under fluoroscopy that the distal end of the stent never exited the guiding catheter and so the entire fractured sds was removed together with the guide catheter.The procedure was completed with another of the same device.No patient harm nor complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr: synergy ii us mr 4.00 x 12mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent od(outer diameter) was measured and 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 bumper tip showed no damage.A visual and tactile examination of the hypotube found a break 725mm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.

• 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: 8138528
• Report Number: 2134265-2018-63472
• Device Sequence Number: 262704
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/11/2019

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: 07/15/2020
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0022411480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1