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

Model Number	10603
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The target lesion was located in a coronary vessel.A 2.50x20mm synergy drug-eluting stent was used in a percutaneous coronary intervention.However, during placement, the device became stuck with the wire and upon pulling the device out, the hypotube broke into pieces.The device was completely removed and the procedure was completed by deploying a new stent with the same size.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The target lesion was located in a coronary vessel.A 2.50x20mm synergy drug-eluting stent was used in a percutaneous coronary intervention.However, during placement, the device became stuck with the wire and upon pulling the device out, the hypotube broke into pieces.The device was completely removed and the procedure was completed by deploying a new stent with the same size.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device codes corrected from difficult to remove 1528 to entrapment of device 1212.A synergy ii us mr 2.50 x 20mm stent delivery system was returned for analysis in two pieces.A visual and microscopic examination of the stent found stent damage along the entire length of the stent with stent struts lifted and bunched, and with the stent moved proximally on the balloon, past the proximal markerband.The visible sections of the balloon were reviewed and no issues were noted.The distal balloon wing was tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp markings were visible on the exposed balloon wall.A visual and microscopic examination of the bumper tip found distal tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found a shaft polymer extrusion break located 5.5cm proximal to the distal tip.The shaft polymer extrusion was stretched and coiled and damaged at several locations along the length of the shaft.A recommended 0.0140 guidewire could not be loaded via the tip due to tip damage, and could not be loaded via the port exit site due to the shaft break.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: 9706928
• Report Number: 2134265-2020-01333
• Device Sequence Number: 3341806
• Product Code: NIQ
• UDI-Device Identifier: 08714729840152
• UDI-Public: 08714729840152
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 04/06/2020

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: 09/11/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024472043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1