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

Model Number	10618
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Activation Failure (3270)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9596622
• Report Number: 2134265-2020-00175
• Device Sequence Number: 2423395
• Product Code: NIQ
• UDI-Device Identifier: 08714729973355
• UDI-Public: 08714729973355
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention