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	H7493926024350
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr: synergy ii us mr 3.50 x 24mm stent delivery system was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.The mid-section stent row was damaged with stent struts being damaged and lifted from the stent profile.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube found multiple kinks along the full length of the catheter.A visual and tactile examination of shaft polymer extrusion revealed no issues.A visual and microscopic examination found 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 03-aug-2018.It was reported that crossing difficulties were encountered.The target lesion was located in a coronary artery.A 3.50 x 24 synergy ii drug-eluting stent was advanced but failed to cross the lesion.No patient complications were reported.However, returned device analysis revealed 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: 7823429
• Report Number: 2134265-2018-07361
• Device Sequence Number: 13820206
• Product Code: NIQ
• UDI-Device Identifier: 08714729840244
• UDI-Public: 08714729840244
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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: 04/06/2019
• Device Model Number: H7493926024350
• Device Catalogue Number: 39260-2435
• Device Lot Number: 22029672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1