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

Model Number	10603
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that the device had difficulty withdrawing into the sheath.A 4.00x20 synergy ii drug eluting stent and 190cm filterwire ez were selected for a percutaneous coronary intervention (pci) of the saphenous vein graft (svg) procedure.During the procedure, the filter was deployed and percutaneous transluminal coronary angioplasty (ptca) was done.However, the balloon of the synergy ii des stent delivery system was not able to pull back through the sheath and was not able to be re-sheath as there was something wrong with the device.The filter wire and balloon of the synergy were then pulled out together as the balloon could not be pulled out by itself over the filter wire.The procedure was completed with another of the same devices.No patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by the manufacturer: the stent delivery system was returned for analysis.The stent was deployed during the procedure.The review showed that the stent crimp force, the crimp temperature and the maximum crimped stent profile for the device were all within specification.A red-brown like substance present on the balloon body, shaft polymer extrusion and inside the haemostatic valve.The balloon was reviewed.Bunching/ stretching of the distal blue inner was identified 7.5cm proximal to the distal end of the tip.A visual and tactile examination of the hypotube found multiple kinks.A visual and tactile examination of the shaft polymer extrusion found multiple kinks.An examination (visual and via scope) found no issues with the tip.The device inflated without any issues but deflated in 1min 35 seconds.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the device had difficulty withdrawing into the sheath.A 4.00x20 synergy ii drug eluting stent and 190cm filterwire ez were selected for a percutaneous coronary intervention (pci) of the saphenous vein graft (svg) procedure.During the procedure, the filter was deployed and percutaneous transluminal coronary angioplasty (ptca) was done.However, the balloon of the synergy ii des stent delivery system was not able to pull back through the sheath and was not able to be re-sheath as there was something wrong with the device.The filter wire and balloon of the synergy were then pulled out together as the balloon could not be pulled out by itself over the filter wire.The procedure was completed with another of the same devices.No patient complications reported and the patient was fine.

• 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: 9100304
• Report Number: 2134265-2019-11464
• Device Sequence Number: 2700992
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 10/25/2019

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 Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023663011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1