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

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2020

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that shaft break occurred.The target lesion was located in the coronary artery.A synergy drug-eluting stent was advanced and successfully implanted.However, the distal part art of the stent delivery system broke off and the system balloon appeared to be a little bit stretched.Everything was removed altogether and the procedure was completed.There were no patient complications nor injuries reported and patient was fine.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: synergy ii des stent delivery system was returned for analysis without the stent, the hypotube shaft and the manifold hub therefore no catheter lot number or device size could be confirmed.A visual examination of the stent found that the stent was not returned as it was positioned and deployed successfully at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted as its wings were relaxed and not tightly folded.Red/brown blood like substance noted inside/outside the balloon cones.A visual and microscopic examination of the bumper tip showed signs of distal tip damage.A visual examination of the hypotube found that the hypotube shaft of the device including the manifold hub was not returned with the device.A visual and tactile examination of the outer and mid-shaft section found a break in the shaft polymer extrusion measured at 28.5 cm proximal to the distal end of the tip.No other issues were identified during the product analysis.

Event Description

It was reported that shaft break occurred.The target lesion was located in the coronary artery.A synergy drug-eluting stent was advanced and successfully implanted.However, the distal part of the stent delivery system broke off and the system balloon appeared to be a little bit stretched.Everything was removed altogether and the procedure was completed.There were no patient complications nor injuries reported and the patient was fine.

• 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: 9661583
• MDR Text Key: 179230478
• Report Number: 2134265-2020-00827
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1