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	H7493926008220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the tortuous coronary artery in which a stent had been previously implanted.A 2.25 x 8mm synergy ii stent was advanced for to treat the lesion and the stent slipped off from the balloon.Another balloon catheter was advanced and the dislodged stent was expanded properly to complete the procedure.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: synergy ii us mr 2.25 x 8mm stent delivery system (sds) was returned for analysis with the stent detached from the device.No stent returned.Stent separated from sds.The balloon was reviewed.There was no stent on the balloon.The balloon folds were present but were slightly relaxed from their folded position.Crimp markings were evident on the exposed balloon wall, indicating correct positioning and crimping of the stent prior to the event.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.A visual and microscopic examination of the tip found no damage.No other issues were identified during 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 & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.Bsc id# (b)(6).Tw# (b)(4).
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the tortuous coronary artery in which a stent had been previously implanted.A 2.25 x 8mm synergy ii stent was advanced for to treat the lesion and the stent slipped off from the balloon.Another balloon catheter was advanced and the dislodged stent was expanded properly to complete the procedure.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: 7327700
• Report Number: 2134265-2018-01667
• Device Sequence Number: 13817024
• Product Code: NIQ
• UDI-Device Identifier: 08714729839965
• UDI-Public: 08714729839965
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2018
• Device Model Number: H7493926008220
• Device Catalogue Number: 39260-0822
• Device Lot Number: 0021063553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR