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	H7493926032270
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
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 32mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent identified stent damage.The fourth most proximal stent strut row was damaged; struts were lifted and bend back distally.The undamaged section of the crimped stent outer diameter (od) was measured which is within maximum 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 severe hypotube kinks.A visual and tactile examination of shaft polymer extrusion 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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2017.It was reported that crossing difficulties were encountered.The target lesion was located in a coronary artery.A 2.75 x 32mm synergy ii drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with a different device.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: 6811409
• Report Number: 2134265-2017-08562
• Device Sequence Number: 2066617
• Product Code: NIQ
• UDI-Device Identifier: 08714729840343
• UDI-Public: (01)08714729840343(17)20180404(10)20511370
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/11/2017

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: 04/04/2018
• Device Model Number: H7493926032270
• Device Catalogue Number: 39260-3227
• Device Lot Number: 20511370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1