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	H7493926016270
Medical Device Problem Codes	Bent (1059); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: 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
Same case as mdr id: 2134265-2017-04630 it was reported that stent moved on balloon and stent damage occurred.The target lesion was located in the circumflex artery.A 3.00 x 16 synergy ii everolimus-eluting platinum chromium coronary stent system was advanced to treat the lesion but came off of the balloon.The physician was unable to retrieve the stent and a small balloon was used to deploy the stent in the coronary artery.Subsequently, a 2.75 x 16 synergy ii everolimus-eluting platinum chromium coronary stent system was advanced but moved on the balloon on the distal end and some struts were "jetted out".The device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable and good.
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy ii us mr 2.75 x 16mm stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent revealed severe damage.The stent was severely damaged and moved distally on the balloon.The manufacturing data for this device was reviewed and there were no issues to note.The crimp temperature, crimp force and maximum crimped stent profile were all within specification.The maximum stent profile was within specification.There were no issues to note with the balloon.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There were crimp markings evident on the exposed balloon wall indicating overall crimp contact between the balloon and the stent at the time of manufacture.A visual and tactile examination of the device found multiple kinks along the full catheter length.An examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage.The tip was visually and microscopically examined and slight damage was noted.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
Same case as mdr id: 2134265-2017-04630.It was reported that stent moved on balloon and stent damage occurred.The target lesion was located in the circumflex artery.A 3.00 x 16 synergy ii everolimus-eluting platinum chromium coronary stent system was advanced to treat the lesion but came off of the balloon.The physician was unable to retrieve the stent and a small balloon was used to deploy the stent in the coronary artery.Subsequently, a 2.75 x 16 synergy ii everolimus-eluting platinum chromium coronary stent system was advanced but moved on the balloon on the distal end and some struts were "jetted out".The device was completely removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable and good.

• 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: 6538091
• Report Number: 2134265-2017-04683
• Device Sequence Number: 16558823
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: (01)08714729840107(17)20170920(10)19761511
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 04/20/2017

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: 09/20/2017
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 19761511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 08/29/2017
• 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: Other