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	H7493926032250
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	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-02369.It was reported that stent damaged and stent dislodgement occurred.The target lesion was located in the circumflex artery.A 2.00mm x 20mm nc emerge® balloon catheter was advanced to dilate the lesion.However, upon inflation, the balloon ruptured at 20 atmospheres.The device was removed and the physician noticed that the balloon had completely came off from the delivery system and remained in the body.Subsequently, a stent was advanced and was deployed to cover the detached balloon.After that, a 2.50 x 32mm synergy ii stent was advanced but failed to cross the lesion.The device caught on the previously deployed stent and the stent appeared to be unraveled.The device was removed from the patient's body and it was noted that the stent came off on the back table outside the patient's body.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy ii us mr 2.50 x 32mm stent delivery system was returned for analysis.The stent was returned detached and separated from the sds.The stent was severely damaged and stretched.The manufacturing data for this device was reviewed and no anomalies were highlighted.The maximum stent profile was found to be within the specification.The balloon body was reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There were crimp markings evident on the entire length of the balloon wall indicating overall crimp contact between the stent and the balloon 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 profile revealed multiple kinks on the proximal and distal side of the bi-component bond.The tip profile was visually and microscopically examined and no issues were 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
It was reported that stent damaged and stent dislodgement occurred.The target lesion was located in the circumflex artery.A 2.00mm x 20mm nc emerge® balloon catheter was advanced to dilate the lesion.However, upon inflation, the balloon ruptured at 20 atmospheres.The device was removed and the physician noticed that the balloon had completely came off from the delivery system and remained in the body.Subsequently, a stent was advanced and was deployed to cover the detached balloon.After that, a 2.50 x 32mm synergy ii stent was advanced but failed to cross the lesion.The device caught on the previously deployed stent and the stent appeared to be unraveled.The device was removed from the patient's body and it was noted that the stent came off on the back table outside the patient's body.No patient complications were reported.

• 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: 6427013
• Report Number: 2134265-2017-02370
• Device Sequence Number: 16153773
• Product Code: NIQ
• UDI-Device Identifier: 08714729840336
• UDI-Public: (01)08714729840336(17)20170517(10)19281928
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/06/2017

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: 05/17/2017
• Device Model Number: H7493926032250
• Device Catalogue Number: 39260-3225
• Device Lot Number: 19281928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR