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	H7493926008350
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.50 x 8 synergy drug-eluting stent was selected for use to treat a lesion.The device was advanced over a guide wire, through the guide catheter; however, a stent "floating" on the shaft of the delivery system was noted.The delivery system was removed from the wire.However, upon inspection, there was the crimped stent on the balloon along with the "floating" stent.The device was never used inside the patient's body.The procedure was completed using a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy ii, us, mr 3.5x8mm, stent delivery system was returned for analysis.The device was returned with a ¿floating¿ stent on the catheter shaft.The product mandrel was removed from the device and not returned.A visual examination of the crimped stent found there was no visible damage on the crimped stent.The crimped stent outer diameter measured using snap gauge and is within the maximum crimped stent specification and there were no issues with the crimp stent profile.A visual examination of the balloon was performed and no issues were identified with the balloon cones.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There was a reddish medium present in the balloon folds.As part of analysis the balloon was inflated, using an encore hand held inflation device the balloon was inflated to rated burst pressure (rbp) and no issues were noted.The stent deployed with no issue and the deflation time was 2.89 seconds.A visual and tactile examination found an additional stent loaded on the hypotube.The ¿floating¿ stent was damaged with struts overlapping and crushed.There were 7 strut rows on the stent.It appeared to be in an expanded state.The ¿floating¿ stent was removed distally from the device.A visual and tactile examination found no issue with the shaft polymer extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.The stents were returned and reunited with the delivery system.No other damage noted on the device during analysis.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 3.50 x 8 synergy drug-eluting stent was selected for use to treat a lesion.The device was advanced over a guide wire, through the guide catheter; however, a stent "floating" on the shaft of the delivery system was noted.The delivery system was removed from the wire.However, upon inspection, there was the crimped stent on the balloon along with the "floating" stent.The device was never used inside the patient's body.The procedure was completed using a different device.No patient complications were reported.

• 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: 7429079
• Report Number: 2134265-2018-02952
• Device Sequence Number: 11301926
• Product Code: NIQ
• UDI-Device Identifier: 08714729840008
• UDI-Public: 08714729840008
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2018
• Device Model Number: H7493926008350
• Device Catalogue Number: 39260-0835
• Device Lot Number: 0021518335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR