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	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that the stent moved on balloon.The target lesion was located in the circumflex artery.A 2.25 x 8mm synergy ii stent was advanced and had difficulty passing through two implanted stents and ultimately did not cross.Upon drawing the device back, the stent moved on the balloon.The stent and delivery system were able to be pulled out as the proximal section of the stent was still attached.The procedure was completed with another synergy stent.No patient complications were reported and the patient was well.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 2.25 x 8mm stent delivery system was returned for analysis.The stent was damaged the entire length and had moved in a distal direction on the balloon.The distal stent struts were bunched and overlapping.The manufacturing crimp data for this device was reviewed and there were no issues noted with the production of this unit.The maximum stent profile was within spcification.The balloon cones were reviewed and no issues were noted.The balloon had not been subjected to any significant positive pressure.There were crimp markings evident on exposed section of the balloon wall indicating crimp contact between the balloon and the stent at the time of manufacture.A visual and tactile examination of the device revealed multiple hypotube kinks.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 damaged 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 investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that the stent moved on balloon.The target lesion was located in the circumflex artery.A 2.25 x 8mm synergy ii stent was advanced and had difficulty passing through two implanted stents and ultimately did not cross.Upon drawing the device back, the stent moved on the balloon.The stent and delivery system were able to be pulled out as the proximal section of the stent was still attached.The procedure was completed with another synergy stent.No patient complications were reported and the patient was well.

• 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: 7426769
• Report Number: 2134265-2018-02962
• Device Sequence Number: 145374
• Product Code: NIQ
• UDI-Device Identifier: 08714729839965
• UDI-Public: 08714729839965
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/21/2018

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: 08/21/2018
• 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: 04/04/2018
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 05/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1