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	H7493926032350
Medical Device Problem Codes	Bent (1059); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Sane case as mdr id: 2134265-2018-05633.It was reported that stent damage occurred.The target lesion was located in a coronary artery.A 6f guidezilla¿ ii long guide extension catheter was in use while a 3.50 x 32 synergy ii drug-eluting stent was advanced for treatment.When the physician attempted to remove the stent, it was snagged by the guidezilla¿ and became unusable.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Updated device evaluated by mfr., eval summary attached, method codes, result codes and conclusion codes.Device evaluated by mfr: a synergy ii us mr 3.50 x 32mm stent delivery system was returned for analysis.A visual examination of the crimped stent identified damage.Distal struts 1-4 were undamaged; the remainder of the struts were damaged and deformed.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 device revealed multiple hypotube kinks.An examination of the shaft polymer extrusion revealed multiple inner/outer shaft polymer extrusion kinks, the corewire was kinked in several locations.The tip was visually and microscopically examined and no issues were noted.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 caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
Sane case as mdr id: 2134265-2018-05633.It was reported that interaction with another device during withdrawal occurred.The target lesion was located in a coronary artery.A 6f guidezilla¿ ii long guide extension catheter was in use while a 3.50 x 32 synergy ii drug-eluting stent was advanced for treatment.When the physician attempted to remove the stent, it was snagged by the guidezilla¿ and became unusable.No patient complications were reported and the patient's 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: 7630846
• Report Number: 2134265-2018-05620
• Device Sequence Number: 14081486
• Product Code: NIQ
• UDI-Device Identifier: 08714729840367
• UDI-Public: 08714729840367
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/30/2018

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: 08/21/2018
• Device Model Number: H7493926032350
• Device Catalogue Number: 39260-3235
• Device Lot Number: 21065948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1