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

Model Number	10607
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that removal difficulties occurred.The target lesion was located in the left anterior descending artery.After using a 1.5 rotablator burr, a 2.5x15 wolverine and 2.5mm nc emerge balloon catheter were used for pre-dilation.A 2.50 x 38mm synergy drug-eluting stent was successfully deployed.However, during removal of the delivery system, it was noted that the balloon was stuck inside the stent.Another balloon was inflated to trap the wire and stent delivery system shaft inside the guide catheter.The stent balloon came free as everything was removed together.The stent remained implanted and was post dilated to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.B5 describe event or problem updated.Device evaluated by mfr.: synergy ii us mr 2.50 x 38 mm stent delivery system was returned for analysis without the distal section containing the inner/outer shaft polymer extrusion, balloon and stent.A visual examination of the stent, balloon, tip profiles and distal end of the shaft polymer extrusion profile could not be completed as the device was returned without these sections.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found a break in the midshaft region of the shaft polymer extrusion measured at 123.5 cm distal to distal end of the strain relief.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that removal difficulties occurred.The target lesion was located in the left anterior descending artery.After using a 1.5 rotablator burr, a 2.5x15 wolverine and 2.5mm nc emerge balloon catheter were used for pre-dilation.A 2.50 x 38mm synergy drug-eluting stent was successfully deployed.However, during removal of the delivery system, it was noted that the balloon was stuck inside the stent.Another balloon was inflated to trap the wire and stent delivery system shaft inside the guide catheter.The stent balloon came free as everything was removed together.The stent remained implanted and was post dilated to complete the procedure.No patient complications were reported.It was further reported that after stent deployment, the shaft broke while removing the delivery system.

• 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: 10189966
• Report Number: 2134265-2020-07666
• Device Sequence Number: 3017029
• Product Code: NIQ
• UDI-Device Identifier: 08714729840398
• UDI-Public: 08714729840398
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2021
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024325405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention