MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	H7493926020220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.A 2.25 x 20mm synergy ii drug-eluting stent was selected for use to treat the lesion.However, the shaft broke while attempting to insert the device inside the patient's body.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was further reported that the target lesion was 90% stenosed and was located in a moderately tortuous and moderately calcified vessel.The device met resistance while advancing inside the guide catheter and the hypotube kinked and eventually broke.The device was completely removed from the patient.
Additional Manufacturer Narrative
Describe event or problem, device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: synergy ii us mr 2.25 x 20mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found a hypotube break 835mm distal to the distal end of the strain relief and multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.Na visual and microscopic examination found no damage to the tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7283859
• Report Number: 2134265-2018-01037
• Device Sequence Number: 164502
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: 08/21/2018
• Device Model Number: H7493926020220
• Device Catalogue Number: 39260-2022
• Device Lot Number: 21060797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1