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	H7493926028220
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
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 dislodgement occurred.The target lesion was located in a very calcified and tortuous right coronary artery (rca).With a support of a non-bsc guide extension catheter, a 2.25x28mm synergy ii everolimus-eluting platinum chromium coronary stent system was advanced to treat the lesion.However, delivering difficulties were encountered.The physician then pulled the entire delivery system back into the guide extension catheter.When the physician attempted to re-advance the device, it was noticed that the stent had dislodged from the balloon and was inside the guide extension catheter.The physician removed the entire system together with the dislodged stent in the guide extension catheter.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
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 it was damaged and stretched along the entire length.The maximum crimped stent profile measurement at the time of manufacture is within the specification.Stent damage and dislodgment most likely occurred when the stent was pulled back into the guideliner after difficulties that were encountered in an attempt to deliver the stent.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.Crimp stent markings were present on balloon body indicating that the stent was crimped on the balloon prior to detachment.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive pressure being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion shaft.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 most probable cause of the reported difficulties may be due interaction with another device.(b)(4).
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a very calcified and tortuous right coronary artery (rca).With a support of a non-bsc guide extension catheter, a 2.25x28mm synergy ii everolimus-eluting platinum chromium coronary stent system was advanced to treat the lesion.However, delivering difficulties were encountered.The physician then pulled the entire delivery system back into the guide extension catheter.When the physician attempted to re-advance the device, it was noticed that the stent had dislodged from the balloon and was inside the guide extension catheter.The physician removed the entire system together with the dislodged stent in the guide extension catheter.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: 6633796
• Report Number: 2134265-2017-05912
• Device Sequence Number: 18835184
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: (01)08714729840268(17)20170830(10)19680509
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/24/2017

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: 08/30/2017
• Device Model Number: H7493926028220
• Device Catalogue Number: 39260-2822
• Device Lot Number: 19680509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1