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

Model Number	10603
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: the date of the event was not reported, therefore (b)(6) 2020 was populated as an estimate.
Event or Problem Description
It was reported that device entrapment occurred.A 4.00 x 20 synergy drug eluting stent was loaded onto the wire.Upon advancing the stent delivery system it became stuck on the non-boston scientific guidewire.The delivery system could not be advanced past the distal end of the guide catheter.The physician needed to remove both the stent delivery system and the guidewire from the body as a unit.A new guidewire was advanced and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
B3 date of event updated to (b)(6) 2020.
Event or Problem Description
It was reported that device entrapment occurred.A 4.00 x 20 synergy drug eluting stent was loaded onto the wire.Upon advancing the stent delivery system it became stuck on the non-boston scientific guidewire.The delivery system could not be advanced past the distal end of the guide catheter.The physician needed to remove both the stent delivery system and the guidewire from the body as a unit.A new guidewire was advanced and the procedure was completed.There were no patient complications reported.It was further reported that the wire and the stent were pulled out together the stent likely never even exited the distal end of the guide catheter.It became stuck right after the physician went past the touhy.
Event or Problem Description
It was reported that device entrapment occurred.A 4.00 x 20 synergy drug eluting stent was loaded onto the wire.Upon advancing the stent delivery system it became stuck on the non-boston scientific guidewire.The delivery system could not be advanced past the distal end of the guide catheter.The physician needed to remove both the stent delivery system and the guidewire from the body as a unit.A new guidewire was advanced and the procedure was completed.There were no patient complications reported.It was further reported that the wire and the stent were pulled out together the stent likely never even exited the distal end of the guide catheter.It became stuck right after the physician went past the touhy.
Additional Manufacturer Narrative
B3 date of event updated to 08dec2020.Device evaluated by mfr: synergy ii us mr 4.00 x 20mm stent delivery system catheter was returned for analysis.Device was returned with 0.014 guidewire attached - unable to remove wire due to inner damage.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured using a snap gauge and the result is within maximum crimped stent profile measurement.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 examination of the bumper tip showed signs of damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found the inner lumen to be accordioned at multiple locations and the wire-port was damaged.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: 11014044
• Report Number: 2134265-2020-17870
• Device Sequence Number: 3617635
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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: 01/20/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0023243405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/14/2020; 02/05/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/04/2021; 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1