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

Model Number 10601

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 2.75 x 12 synergy drug-eluting stent was selected for use.However, it was noted that the mid shaft of the delivery system broke on the table while trying to load the device onto the wire.The device never entered into the patient's body and the procedure was completed with a different device.No patient complications nor injuries were reported.

Event Description

It was reported that shaft break occurred.A 2.75 x 12 synergy drug-eluting stent was selected for use.However, it was noted that the mid shaft of the delivery system broke on the table while trying to load the device onto the wire.The device never entered into the patient's body and the procedure was completed with a different device.No patient complications nor injuries were reported.

Manufacturer Narrative

Device evaluated by mfr: synergy ii us mr 2.75 x 12mm stent delivery system (sds) 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 outer diameter was measured using snap gauge and the result is 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 issues.A visual and tactile examination of the hypotube shaft found a break situated at 86cm distal to the distal end of the strain.Also, multiple kinks located at different places 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.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10733880
• MDR Text Key: 213009861
• Report Number: 2134265-2020-14319
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: 08714729840046
• Combination Product (y/n): N
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024433205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 11/16/2020
• Supplement Dates FDA Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1