MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number 10618

Device Problems Difficult to Remove (1528); Material Rupture (1546); Activation Failure (3270)

Patient Problem Perforation (2001)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that stent insufficient apposition, catheter removal difficulty, balloon rupture, and vessel perforation occurred.The patient presented with st-elevation myocardial infarction (stemi).The target lesion was located in the moderately calcified right coronary artery to posterior descending artery.Pre-dilatation was performed with emerge balloon catheter, but the balloon was not fully inflating due to calcium or fibrotic lesion.A 4.50 x 16 synergy drug-eluting stent was advanced for treatment.However, there was still a waste in the middle of the stent and it would not fully expand.When the balloon was attempted to retrieve, the balloon was stuck inside the stent.The stent balloon was then inflated again to release the stent, but it burst.Immediately after, a perforation was noted just proximal to the stent.A stent was placed to seal the perforation and the procedure was completed.No further patient complications were reported and the patient was doing fine.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.50 x 16 mm stent delivery system was returned for analysis without the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed, and signs of positive pressure applied to the cones were noted.A tear was noted on the balloon body measured at 0.5 cm from the proximal balloon bond and extending distally for 12 mm.A red/brown substance was noted inside the balloon.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along several location of the hypotube shaft as well as a red/brown substance inside the manifold hub.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.

Event Description

It was reported that stent insufficient apposition, catheter removal difficulty, balloon rupture, and vessel perforation occurred.The patient presented with st-elevation myocardial infarction (stemi).The target lesion was located in the moderately calcified right coronary artery to posterior descending artery.Pre-dilatation was performed with emerge balloon catheter, but the balloon was not fully inflating due to calcium or fibrotic lesion.A 4.50 x 16 synergy drug-eluting stent was advanced for treatment.However, there was still a waste in the middle of the stent and it would not fully expand.When the balloon was attempted to retrieve, the balloon was stuck inside the stent.The stent balloon was then inflated again to release the stent, but it burst.Immediately after, a perforation was noted just proximal to the stent.A stent was placed to seal the perforation and the procedure was completed.No further patient complications were reported and the patient was doing fine.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9596622
• MDR Text Key: 175908601
• Report Number: 2134265-2020-00175
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729973355
• UDI-Public: 08714729973355
• Combination Product (y/n): N
• PMA/PMN Number: P150003/S039
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2021
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0024655945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention