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	H7493926028400
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified distal to the vein graft of the circumflex.After deploying a 4.0x20 mm synergy stent in the ostium of the vein graft, the physician decided to a treat a distal lesion.The vein graft was re-engaged and a non-bsc wire was advanced.A 4.00x28 mm synergy ii stent was then advanced to treat the target lesion.However, the stent caught up with the previously deployed stent and was damaged.The device was removed together with guide catheter, guide wire and guidezilla.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was fine.
Event or Problem Description
It was reported that stent damage occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified distal to the vein graft of the circumflex.After deploying a 4.0x20mm synergy stent in the ostium of the vein graft, the physician decided to a treat a distal lesion.The vein graft was re-engaged and a non-bsc wire was advanced.A 4.00x28mm synergy ii stent was then advanced to treat the target lesion.However, the stent caught up with the previously deployed stent and was damaged.The device was removed together with guide catheter, guide wire and guidezilla.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr, eval summary, method codes, result codes, conclusion codes updated.Device evaluated by mfr: synergy ii us mr 4.00 x 28mm stent delivery system (sds) was returned for analysis inside a guide catheter loaded on a 0.0135" guidewire.A visual examination of the crimped stent identified damage.The proximal strut rows were damaged and bunched in a distal direction exposing the proximal section of the balloon wall.The remainder of the stent was undamaged.The undamaged crimped stent outer diameter was measured and the result was within the 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 device revealed no issues.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and damage was noted.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(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: 7690402
• Report Number: 2134265-2018-06330
• Device Sequence Number: 751975
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/22/2018

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: 10/25/2018
• Device Model Number: H7493926028400
• Device Catalogue Number: 39260-2840
• Device Lot Number: 21326286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE EXTENSION CATHETER: GUIDEZILLA; GUIDE WIRE: BMW; STENT: 4.0 X 20MM SYNERGY
• Patient Age: 42 YR