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

Model Number	10604
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.The target lesion was located in the circumflex artery.Following pre-dilation of a 3.0mm and 3.5mm nc emerge balloon catheter, a 4.00 x 24mm synergy drug-eluting stent was successfully implanted past the nominal pressure.However, when the delivery system was removed, the device was stuck and the shaft broke inside the guide catheter when pulled harder.The guide was pushed in as the entire delivery system was pulled out completely.The stent was post-dilated with a 5.0mm nc emerge balloon catheter, completing the procedure.No further complications were reported.
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.The target lesion was located in the circumflex artery.Following pre-dilation of a 3.0mm and 3.5mm nc emerge balloon catheter, a 4.00 x 24mm synergy drug-eluting stent was successfully implanted past the nominal pressure.However, when the delivery system was removed, the device was stuck and the shaft broke inside the guide catheter when pulled harder.The guide was pushed in as the entire delivery system was pulled out completely.The stent was post-dilated with a 5.0mm nc emerge balloon catheter, completing the procedure.No further complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 24mm stent delivery system was returned for analysis.The device was returned without the stent attached.The balloon cones were reviewed, the cones were identified to be in a deflated state with a red/brown substance visible.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks as well as a red/brown substance visible in the manifold.A visual examination of the outer and inner lumen and mid-shaft section found the device broken at the guidewire exchange port 260mm proximal to the distal tip.The corewire was exposed.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: 10191763
• Report Number: 2134265-2020-07669
• Device Sequence Number: 13674779
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 09/09/2021
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0024455130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1