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	H7493926012400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending (lad) artery.A 4.00 x 12 synergy ii drug-eluting stent was advanced to treat the lesion.However, before the stent could fully advance into the guide catheter, the shaft was bent and broke at approximately 25cm from the hub outside the patient's body.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 4.00 x 12mm stent delivery system (sds) was returned for analysis.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal marker bands.The crimped stent outer diameter (od) was measured and was within the maximum crimped stent specification. the balloon was 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 a hypotube break 565mm distal to the distal end of the strain relief and multiple kinks along the hypotube.A visual and tactile examination of the shaft polymer extrusion revealed no issues.A visual and microscopic examination of the tip found no issues.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 shaft break occurred.The target lesion was located in the left anterior descending (lad) artery.A 4.00 x 12 synergy ii drug-eluting stent was advanced to treat the lesion.However, before the stent could fully advance into the guide catheter, the shaft was bent and broke at approximately 25cm from the hub outside the patient's body.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was good.

• 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: 6772631
• Report Number: 2134265-2017-07786
• Device Sequence Number: 19143256
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: (01)08714729840077(17)20180131(10)0020248713
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/19/2017

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: 01/31/2018
• Device Model Number: H7493926012400
• Device Catalogue Number: 39260-1240
• Device Lot Number: 0020248713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR