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	H7493926032250
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/17/2017
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 2.50 x 32mm synergy ii stent was selected for use to treat the lesion.However, upon removing the stent protective cover, the stent got stuck and fell off of the delivery system.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found that the stent was detached from the sds and damaged and deformed.The maximum crimped stent profile measurement at the time of manufacture was within specification.A stent protector was returned with the device.The stent protector id (inner diameter) was measured and the result was within measurement.The balloon cones were reviewed and no issues were noted.Stent crimp markings were evident on the balloon body and the balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the bumper tip profile showed no signs of damage.A visual and tactile examination of the hypotube profile found no damage.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the shaft polymer extrusion profile.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 most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.50 x 32mm synergy ii stent was selected for use to treat the lesion.However, upon removing the stent protective cover, the stent got stuck and fell off of the delivery system.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: 6484542
• Report Number: 2134265-2017-03443
• Device Sequence Number: 11085057
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: (01)08714729840336(17)20171003(10)19807725
• Combination Product (Y/N): N
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 10/03/2017
• Device Model Number: H7493926032250
• Device Catalogue Number: 39260-3225
• Device Lot Number: 19807725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1