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	H7493926028250
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the mildly tortuous and calcified left anterior descending artery.A 2.50 x 28mm synergy ii drug-eluting stent (des) was advanced to treat the lesion.However, the device was unable to cross and it was noted that the distal end of the stent was damaged.A 2.50 x 15mm emerge balloon catheter was then advanced to pre-dilate the lesion and the procedure was completed with another 2.50 x 28mm synergy ii des.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the synergy ii us mr 2.50 x 28 mm stent delivery system was returned for analysis.A visual examination of the stent found that on the proximal stent strut row 4, a stent strut was lifted.The undamaged section crimped stent maximum outer diameter measurement was within the maximum crimped stent profile measurement.Stent damage most likely occurred during withdrawal attempts.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 at the distal edges of the tip.This type of damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination found multiple kinks along several locations of the hypotube shaft.This type of damage is consistent with excessive force being applied on the delivery system.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the shaft polymer extrusion.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 & 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 stent damage occurred.The target lesion was located in the mildly tortuous and calcified left anterior descending artery.A 2.50 x 28mm synergy ii drug-eluting stent (des) was advanced to treat the lesion.However, the device was unable to cross and it was noted that the distal end of the stent was damaged.A 2.50 x 15mm emerge balloon catheter was then advanced to pre-dilate the lesion and the procedure was completed with another 2.50 x 28mm synergy ii des.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: 7612093
• Report Number: 2134265-2018-05484
• Device Sequence Number: 2222203
• Product Code: NIQ
• UDI-Device Identifier: 08714729840275
• UDI-Public: 08714729840275
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 01/16/2019
• Device Model Number: H7493926028250
• Device Catalogue Number: 39260-2825
• Device Lot Number: 21646435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR