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	H7493926012400
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.  (b)(4).Device evaluated by mfr.: synergy ii us mr 4.00 x 12mm stent delivery system was returned for analysis.A visual and microscopic examination of the stent identified stent damage and movement on the balloon.The stent had moved 6mm in a proximal direction on the balloon.Damage was noted to the proximal stent struts; struts were misaligned and some were situated over the proximal markerband.The distal crimped stent outer diameter was measured and was within the maximum 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.Stent crimp markings were evident on the exposed balloon wall indication correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube identified multiple hypotube kinks.A visual and tactile examination of the shaft polymer extrusion found no issues.A visual and microscopic examination of the tip found no issues.No other issues were identified during the product analysis.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.Dfu states "do not attempt to pull an unexpanded stent back into the guide catheter, as stent or coating damage or stent dislodgment from the balloon may occur.¿¿ (b)(4).
Event or Problem Description
Same case as mdr id#: 2134265-2018-02329 and 2134265-2018-03092.It was reported that stent moved on balloon occurred.The target lesion was located in the circumflex artery.After engaging the lesion with a non-bsc guide catheter and a guidezilla guide extension catheter, a 4.00x12mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device was not placed correctly and the physician then pulled the stent back through both devices.As the physician put the stent back in, the stent got stripped off the balloon at the transition, at the collar of the guidezilla.The stent was removed with the balloon together.Furthermore, a 4.00x16mm synergy ii drug-eluting stent was advanced; however at some point during the procedure, the physician claimed that when the device was removed the balloon looked larger on either side of the stent.Thus, the physician opted not to use the device.The procedure was completed with another synergy 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: 7376842
• Report Number: 2134265-2018-02261
• Device Sequence Number: 11033712
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 02/28/2018

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: 05/02/2018
• Device Model Number: H7493926012400
• Device Catalogue Number: 39260-1240
• Device Lot Number: 0020611381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1