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	H7493926032400
Medical Device Problem Codes	Bent (1059); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A guidezilla¿ ii guide extension catheter was positioned and then a 4.00x32mm synergy ii stent was inserted into the guidezilla.The stent became stuck on the heiloc transition point of the guidezilla ii and was damaged.Everything happened inside of the original guide catheter and everything was removed as one system with ease.There were no patient complications and the patient is doing fine.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual examination of the stent found that the stent had moved 15 mm from the proximal end of the distal markerband in a proximal direction over the polymer extrusion shaft.The stent struts were damaged and squashed.The damaged section of the crimped stent outer diameter was measured, the stent protector could not have fitted to cover the stent during the manufacturing process prior to sterile packaging.Stent damage most likely occurred due to interaction between the guidezilla and the stent.The balloon cones were reviewed and no issues were noted.Stent crimp markings were visible on the balloon body.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual examination of the bumper tip showed no signs of damage.A visual and tactile examination found no kinks along the hypotube shaft.A visual and tactile examination of the outer and mid-shaft polymer extrusion profile 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 investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.A guidezilla¿ ii guide extension catheter was positioned and then a 4.00x32mm synergy ii stent was inserted into the guidezilla.The stent became stuck on the heiloc transition point of the guidezilla ii and was damaged.Everything happened inside of the original guide catheter and everything was removed as one system with ease.There were no patient complications and the patient is doing 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: 6963023
• Report Number: 2134265-2017-10122
• Device Sequence Number: 1549883
• Product Code: NIQ
• UDI-Device Identifier: 08714729840374
• UDI-Public: 08714729840374
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/27/2017

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: 10/10/2017
• Device Model Number: H7493926032400
• Device Catalogue Number: 39260-3240
• Device Lot Number: 0019834093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 10/19/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1