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 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first day of the month of bsc aware date since no event date provided.

Event Description

It was reported that shaft break occurred.A 2.25 x 12mm synergy drug-eluting stent was selected for use.However, the mid shaft broke as it was being advanced through the guide.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.

Event Description

It was reported that shaft break occurred.A 2.25 x 12mm synergy drug-eluting stent was selected for use.However, the mid shaft broke as it was being advanced through the guide.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

B3: date of event - used the first day of the month of bsc aware date since no event date provided.Device evaluated by mfr.: synergy ii us mr 2.25 x 12 mm stent delivery system was returned for analysis broken in the midshaft region of the device and with the distal shaft containing the inner/outer shaft polymer extrusion, bunched balloon, damaged stent and tip stuck on the customer guidewire.The device was returned with the stent damaged on its entire length.Stent struts from the proximal region of the stent were lifted and pulled/bunched in a distal direction.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture.This is within max crimped stent profile measurement.The balloon cones were reviewed, and it was noted that it was bunched proximally.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple hypotube 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 a break in the mid shaft region at the guidewire exchange pert as well as multiple stretching and bunching regions of the inner and outer 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: 10735917
• MDR Text Key: 213070616
• Report Number: 2134265-2020-14361
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840022
• UDI-Public: 08714729840022
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2022
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0025260514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1