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	H7493926008400
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the right coronary artery (rca).After a guidewire crossed the lesion, a rotablator burr was advanced to ablate the lesion but failed to cross the thrombus.Pre-dilatation was then performed with a balloon catheter and a 4.00 x 8 synergy ii stent was advanced to treat the lesion.However, the device failed to cross lesion and it was noted that a strut in the middle part of the stent was lifted up.No further action was taken.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a synergy ii us mr 4.00 x 8mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent found stent damage.Central stent struts rows (rows 4 and 5 counting from the proximal end of stent) were damaged, and lifted from the stent profile.The undamaged section of the crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The balloon cones were reviewed.The wings of the balloon cones were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip identified slight tip damage.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 root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the right coronary artery (rca).After a guidewire crossed the lesion, a rotablator burr was advanced to ablate the lesion but failed to cross the thrombus.Pre-dilatation was then performed with a balloon catheter and a 4.00 x 8 synergy ii stent was advanced to treat the lesion.However, the device failed to cross lesion and it was noted that a strut in the middle part of the stent was lifted up.No further action was taken.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: 6469762
• Report Number: 2134265-2017-03340
• Device Sequence Number: 476855
• Product Code: NIQ
• UDI-Device Identifier: 08714729840015
• UDI-Public: (01)08714729840015(17)20171107(10)19953372
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2017

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: 11/07/2017
• Device Model Number: H7493926008400
• Device Catalogue Number: 39260-0840
• Device Lot Number: 19953372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 05/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1