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	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-03568.It was reported that stent damage occurred.The target lesion was located in the calcified ostial right coronary artery.A 4.00 x 28mm synergy ii drug-eluting stent was advanced through a 6f guidezilla¿ ii guide extension catheter.However, it was noted that the stent penetrated the calcium and the distal edge of the stent was dinged up.When the device was removed, the proximal end got caught on the guidezilla ii guide extension catheter and the stent was quashed or squeezed.The physician removed the entire system out and then re-engaged and completed the procedure with a 4.00 x 12mm synergy ii drug-eluting stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device lot number, device expiration date, device manufactured date, device evaluated by mfr.,eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis loaded in a guidezilla device.A visual and microscopic examination of the crimped stent identified proximal stent damage.Proximal stent struts were damaged; squashed and overlapping.The undamaged crimped stent outer diameter was within maximum crimped stent profile measurement.No issues were noted with the distal balloon cone; the wings of the balloon cone were tightly wrapped and evenly folded and were not subjected to positive pressure.The proximal balloon cone and shaft polymer extrusion could not be visually inspected as they were covered by the guidezilla catheter.A visual and tactile examination found multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip identified tip damage.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 amp; manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-03568.It was reported that stent damage occurred.The target lesion was located in the calcified ostial right coronary artery.A 4.00 x 28mm synergy ii drug-eluting stent was advanced through a 6f guidezilla¿ ii guide extension catheter.However, it was noted that the stent penetrated the calcium and the distal edge of the stent was dinged up.When the device was removed, the proximal end got caught on the guidezilla ii guide extension catheter and the stent was quashed or squeezed.The physician removed the entire system out and then re-engaged and completed the procedure with a 4.00 x 12mm synergy ii drug-eluting stent.No patient complications were reported and the patient's status was fine.

• 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: 7470653
• Report Number: 2134265-2018-03565
• Device Sequence Number: 18860420
• Product Code: NIQ
• UDI-Device Identifier: 08714729840312
• UDI-Public: 08714729840312
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/04/2018

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: 09/01/2018
• Device Model Number: H7493926028400
• Device Catalogue Number: 39260-2840
• Device Lot Number: 21114263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1