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

Model Number	10605
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 4.00 x 28 synergy drug-eluting stent was deployed to treat the lesion.However, when the stent delivery system was attempted to be removed, the distal shaft broke and only the proximal portion came out.Therefore, the non-bsc wire was retracted and the distal portion of the balloon delivery system came out with it into the non-bsc guide catheter and the device was completely removed from the patient.The procedure was successfully completed with this device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 4.00 x 28 synergy drug-eluting stent was deployed to treat the lesion.However, when the stent delivery system was attempted to be removed, the distal shaft broke and only the proximal portion came out.Therefore, the non-bsc wire was retracted and the distal portion of the balloon delivery system came out with it into the non-bsc guide catheter and the device was completely removed from the patient.The procedure was successfully completed with this device.There were no patient complications reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00 x 28 mm stent delivery system (sds) was returned for analysis without the distal portion of the device, including port bond, polymer extrusion and balloon.The stent was not returned as it was successfully implanted.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found and a break 122.1cm distal to the distal end of the strain relief.The clear outer lumen is stretched proximal to the break site and the core wire is 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: 8811599
• Report Number: 2134265-2019-08511
• Device Sequence Number: 2417988
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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: 12/18/2020
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0023133006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1