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

Model Number	10607
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that balloon removal difficulties occurred.The target lesion was located in the non-tortuous and non-calcified right coronary artery.A 4.00 x 38 synergy drug-eluting stent was deployed to treat the lesion.Post stent deployment, the balloon deflated but would not re-wrap and became stuck at the distal end of the catheter.The entire system had to be taken out to remove the balloon.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon removal difficulties occurred.The target lesion was located in the non-tortuous and non-calcified right coronary artery.A 4.00 x 38 synergy drug-eluting stent was deployed to treat the lesion.Post stent deployment, the balloon deflated but would not re-wrap and became stuck at the distal end of the catheter.The entire system had to be taken out to remove the balloon.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.00 x 38mm stent delivery system, catheter was returned for analysis inside a guidecatheter with guidewire inserted.The device was removed without issues from guide catheter by pulling it proximally.The guidewire was removed though the distal tip of the device without issue.The device was returned without the stent.The balloon was reviewed, and issues were noted.No stent was attached to the balloon and the balloon appeared to have had positive pressure applied (inflated/deflated) and is bunched in the distal region.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.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.The encore inflation device was attached to synergy device and the balloon was inflated to 16 atm and the balloon was successfully expanded for 25 seconds.A vacuum was pulled using the encore device and the balloon deflated fully after 18 seconds.The encore device was verified before and after the procedure using a druck gauge.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10310305
• Report Number: 2134265-2020-09097
• Device Sequence Number: 3246904
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024361060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1