MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number	10604
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter removal difficulties were encountered and stent damage occurred.The target lesion was located in the left circumflex artery.A 4.00 x 24 synergy drug-eluting stent was advanced but failed to cross the lesion.While removing the device from the vessel, it would not come out.The wire and stent were able to be removed after multiple attempts.It was then noted that the stent was fractured on the balloon.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that catheter removal difficulties were encountered and stent damage occurred.The target lesion was located in the left circumflex artery.A 4.00 x 24 synergy drug-eluting stent was advanced but failed to cross the lesion.While removing the device from the vessel, it would not come out.The wire and stent were able to be removed after multiple attempts.It was then noted that the stent was fractured on the balloon.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was completely removed by pulling the wire, stent and stent balloon all together out of the vessel.The stent was noted to be lifted or fractured on the balloon, but was not separated into two pieces.
Event or Problem Description
It was reported that catheter removal difficulties were encountered and stent damage occurred.The target lesion was located in the left circumflex artery.A 4.00 x 24 synergy drug-eluting stent was advanced but failed to cross the lesion.While removing the device from the vessel, it would not come out.The wire and stent were able to be removed after multiple attempts.It was then noted that the stent was fractured on the balloon.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was completely removed by pulling the wire, stent and stent balloon all together out of the vessel.The stent was noted to be lifted or fractured on the balloon, but was not separated into two pieces.Device evaluated by manufacturer: synergy ii us mr 4.00 x 24mm stent delivery system (sds) was returned for analysis inside the guide catheter and tracked over a guidewire.A visual and microscopic examination of the crimped stent found damage to the stent.The mid and proximal sections of the stent were damaged with stent struts bunched and lifted from the stent profile.The stent had also moved in a distal direction along the balloon.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 visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the proximal portion of the shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Device is combination product.
Additional Manufacturer Narrative
Device is combination product.
Event or Problem Description
It was reported that catheter removal difficulties were encountered and stent damage occurred.The target lesion was located in the left circumflex artery.A 4.00 x 24 synergy drug-eluting stent was advanced but failed to cross the lesion.While removing the device from the vessel, it would not come out.The wire and stent were able to be removed after multiple attempts.It was then noted that the stent was fractured on the balloon.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was completely removed by pulling the wire, stent and stent balloon all together out of the vessel.The stent was noted to be lifted or fractured on the balloon, but was not separated into two pieces.Device evaluated by manufacturer: synergy ii us mr 4.00 x 24mm stent delivery system (sds) was returned for analysis inside the guide catheter and tracked over a guidewire.A visual and microscopic examination of the crimped stent found damage to the stent.The mid and proximal sections of the stent were damaged with stent struts bunched and lifted from the stent profile.The stent had also moved in a distal direction along the balloon.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 visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the proximal portion of the shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.

• Brand Name: SYNERGY
• Common Device Name: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7799817
• Report Number: 2134265-2018-60321
• Device Sequence Number: 16521591
• Product Code: NIQ
• UDI-Device Identifier: 08714729840251
• UDI-Public: 08714729840251
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2018

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: 01/15/2019
• Device Model Number: 10604
• Device Catalogue Number: 10604
• Device Lot Number: 0021639383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 11/01/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 08/21/2018; 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1