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	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the extremely calcified and tortuous circumflex artery.A 2.25 x 8 synergy ii stent was advanced to treat the lesion.Upon removing the device for further pre-dilatation, the stent came off from the balloon which was then snared out from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found that the stent was returned damaged the whole length and bunched.As part of the analysis, a review of the manufacturing data for the stent profile was performed.The maximum crimped stent profile measurement at the time of manufacture was within the specification.The tip was visually and microscopically examined and slight damages were noted at the distal edges of the tip.This type of damage most likely occurred when the tip was pushed against a restriction.The balloon cones were reviewed and the balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Crimp stent markings were visible on the balloon body which is an indication that the stent was crimped on the balloon prior stent detachment.A visual and tactile examination found no kinks along the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion.The bi-component bond showed no signs of damage or strain.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 and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the extremely calcified and tortuous circumflex artery.A 2.25 x 8 synergy ii stent was advanced to treat the lesion.Upon removing the device for further pre-dilatation, the stent came off from the balloon which was then snared out from the patient's body.The procedure was completed with a different device.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: 6967338
• Report Number: 2134265-2017-10302
• Device Sequence Number: 16531445
• Product Code: NIQ
• UDI-Device Identifier: 08714729839965
• UDI-Public: 08714729839965
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2017

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: 05/04/2018
• Device Model Number: H7493926008220
• Device Catalogue Number: 39260-0822
• Device Lot Number: 0020624129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 11/14/2017
• 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