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

Model Number	10603
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty advancing and stent damage occurred.While outside the patient, a 4.00 x 20 synergy ii drug eluting stent was advanced through a watchdog hemostasis valve, but it was noticed that the stent had crinkled.It was noted that there was resistance in the watchdog while advancing the stent through the touey.The stent was able to advance through the touey, but there was too much resistance to advance further.The stent was pulled back out of the touey and the stent became mangled.It was noted that the stent never went into the patient body.The procedure was completed with another of the same device without issue.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: a 4.00 x 20mm synergy ii delivery system (sds) was returned for analysis.A visual examination of the stent found signs of stent damage.Stent struts in the distal section of stent were lifted and pulled distally, extending passed the distal markerband.The undamaged stent od (outer diameter) was measured and the result was 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 and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found no issues.A visual examination of the outer and inner lumen and mid shaft section found no issues along the shaft polymer extrusion.A verified 0.014 inch guidewire was loaded successfully through the distal end of the tip and exited at the exchange port without issue.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that difficulty advancing and stent damage occurred.While outside the patient, a 4.00 x 20 synergy ii drug eluting stent was advanced through a watchdog hemostasis valve, but it was noticed that the stent had crinkled.It was noted that there was resistance in the watchdog while advancing the stent through the touey.The stent was able to advance through the touey, but there was too much resistance to advance further.The stent was pulled back out of the touey and the stent became mangled.It was noted that the stent never went into the patient body.The procedure was completed with another of the same device without issue.No patient complications were reported in relation to this event.

• 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: 10528586
• Report Number: 2134265-2020-12712
• Device Sequence Number: 16923714
• Product Code: NIQ
• UDI-Device Identifier: 08714729840190
• UDI-Public: 08714729840190
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/22/2020

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: 10/20/2021
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0024704251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1