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	H7493926038220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 70-80 years old.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 mid left anterior descending artery.Following rotational atherectomy, pre-dilation was performed and a stent was deployed.The vessel appeared not prepped enough, thus a 2.25 x 38 synergy ii drug-eluting stent was advanced.However, when the device was pulled out, it was noted that the shaft was broken.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
device evaluated by mfr.: the stent delivery system was returned for analysis without the manifold/hub therefore the catheter serial number could not be identified.A visual examination of the stent found no issues on 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 markerbands.The crimped stent od (outer diameter) was measured and the result was 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.The tip was visually and microscopically examined and signs of damage were noted on the distal edge of the tip.A visual and tactile examination found a hypotube break at 1200mm proximal to the distal end of the tip.The location of the break from the distal end of the strain relief is 240mm.Multiple hypotube kinks were also noted during device examination.The type of damage noted most likely occurred due to excessive forces that could have been applied on the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion shaft.The bi-component bond showed no signs of damage or strain.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 and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the mid left anterior descending artery.Following rotational atherectomy, pre-dilation was performed and a stent was deployed.The vessel appeared not prepped enough, thus a 2.25 x 38 synergy ii drug-eluting stent was advanced.However, when the device was pulled out, it was noted that the shaft was broken.The procedure was completed with a different device.No patient complications were reported.

• 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: 7540365
• Report Number: 2134265-2018-04467
• Device Sequence Number: 1898545
• Product Code: NIQ
• UDI-Device Identifier: 08714729840381
• UDI-Public: 08714729840381
• 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,Followup
• Report Date (Section B): 04/30/2018

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: 01/31/2019
• Device Model Number: H7493926038220
• Device Catalogue Number: 39260-3822
• Device Lot Number: 0021724153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1