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	H7493926028270
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that balloon rupture and balloon removal difficulties were encountered.The target lesion was located in the right coronary artery.A 2.75x28mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the balloon ruptured and it got caught on the stent strut.The device was pulled out as a whole unit.The procedure was completed with another of the same device.No patient complications were reported and the patient status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr:  stent delivery system was returned for analysis.The sds was returned inserted inside a 6f guide catheter.The stent was detached from the delivery system and not returned for analysis.The balloon cones were reviewed and no issues were noted.The balloon wings appeared relaxed from their original folded position and it appeared that positive pressure was applied and a vacuum pulled.The distal balloon cone appeared slightly bunched.An attempt was made to inflate the balloon to rated burst pressure (rbp).However the device held pressure but would not inflate.The device was soaked in waterbath at 37 degrees celsius for 24 hours in order to remove hardened medium.After soaking the device the balloon was inflated slightly and deflated in order to remove the device from the guide catheter.The balloon was then inflated to rbp with no issues.The balloon deflated within 5 seconds using calibrated timer, this is within specification deflation time.However a pinhole leak was noted in the outer polymer extrusion where the corewire had bent and punctured the polymer extrusion.A visual and tactile examination of the device found multiple hypotube kinks along the full length of the catheter.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the inner and outer lumen and mid-shaft section found stretching of the port bond, inner polymer extrusion bunching 1.5 mm distal from the bi-component bond and inner/outer polymer extrusion twisting and kinking 40 mm distal from the guidewire exchange port.No issues were noted along the midshaft.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & 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 balloon rupture and balloon removal difficulties were encountered.The target lesion was located in the right coronary artery.A 2.75x28mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the balloon ruptured and it got caught on the stent strut.The device was pulled out as a whole unit.The procedure was completed with another of the same device.No patient complications were reported and the patient 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: 7119319
• Report Number: 2134265-2017-12347
• Device Sequence Number: 1495696
• Product Code: NIQ
• UDI-Device Identifier: 08714729840282
• UDI-Public: 08714729840282
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/29/2017

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: 08/28/2018
• Device Model Number: H7493926028270
• Device Catalogue Number: 39260-2827
• Device Lot Number: 21102165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1