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	H7493926016400
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
Same case as mdr id#: 2134265-2018-02261 and 2134265-2018-03092.It was reported that the balloon looked larger on either side of the stent.The target lesion was located in the circumflex artery.After engaging the lesion with a non-bsc guide catheter and a guidezilla guide extension catheter, a 4.00x12mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device was not placed correctly and the physician then pulled the stent back through both devices.As the physician put the stent back in, the stent got stripped off the balloon at the transition, at the collar of the guidezilla.The stent was removed with the balloon together.Furthermore, a 4.00x16mm synergy ii drug-eluting stent was advanced; however at some point during the procedure, the physician claimed that when the device was removed the balloon looked larger on either side of the stent.Thus, the physician opted not to use the device.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was fine.
Event or Problem Description
Same case as mdr id#: 2134265-2018-02261 and 2134265-2018-03092.It was reported that the balloon looked larger on either side of the stent.The target lesion was located in the circumflex artery.After engaging the lesion with a non-bsc guide catheter and a guidezilla guide extension catheter, a 4.00x12mm synergy ii drug-eluting stent was advanced to treat the lesion.However, the device was not placed correctly and the physician then pulled the stent back through both devices.As the physician put the stent back in, the stent got stripped off the balloon at the transition, at the collar of the guidezilla.The stent was removed with the balloon together.Furthermore, a 4.00x16mm synergy ii drug-eluting stent was advanced; however at some point during the procedure, the physician claimed that when the device was removed the balloon looked larger on either side of the stent.Thus, the physician opted not to use the device.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr.: synergy ii us mr 4.00 x 16mm stent delivery system was returned for analysis without a stent.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 was measured and 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 balloon inflation/deflation test was then performed.The device was inflated to rated burst pressure using an encore inflation device.The balloon was inflated and stent expanded with no issues and when a vacuum was pulled the balloon deflated in 8 seconds this is within deflation time specification.A visual and tactile examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of shaft polymer extrusion found no issues.A visual and microscopic examination of the tip found damage to the tip edge.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 not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

• 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: 7376832
• Report Number: 2134265-2018-02329
• Device Sequence Number: 10995778
• Product Code: NIQ
• UDI-Device Identifier: 08714729840138
• UDI-Public: 08714729840138
• 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): 02/28/2018

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: 09/12/2018
• Device Model Number: H7493926016400
• Device Catalogue Number: 39260-1640
• Device Lot Number: 21151117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1