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 Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: synergy ii us mr 2.75 x 16mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.Damage was noted to the 3 most proximal stent strut rows; struts were deformed, flared outwards and appear lightly expanded.Damage was noted to the most distal stent strut rows; struts were deformed and flared outwards.The undamaged crimped stent outer diameter was measured and was within maximum crimped stent profile measurement.The balloon cones were reviewed and no damage was noted.The balloon wings were wrapped and folded.The slightly expanded appearance of the proximal end of the stent suggested slight positive pressure may have been applied to the balloon.A visual and tactile examination of the hypotube and shaft polymer extrusion profile revealed no issues.A visual and microscopic examination found no damage to the tip.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 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
Reportable based on device analysis completed on 04-april-2018.It was reported that crossing difficulties were encountered.The target lesion was located in the highly calcified left anterior descending artery.A 2.75 x 16mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed proximal and distal stent damage.

• 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: 7470766
• Report Number: 2134265-2018-03397
• Device Sequence Number: 1642793
• Product Code: NIQ
• UDI-Device Identifier: 08714729840107
• UDI-Public: 08714729840107
• Combination Product (Y/N): N
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2018

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: 12/04/2018
• Device Model Number: H7493926016270
• Device Catalogue Number: 39260-1627
• Device Lot Number: 21509847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR