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

Model Number	10603
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the proximal circumflex.After ablation was performed using a 1.5mm rotaburr a 3.0 x 20 synergy drug-eluting stent (des) was placed.A 2.25 x 20 synergy des was advanced but failed to cross the lesion.When the 2.25 x 20 synergy des was removed from the patient's body, it was noticed that the stent was dislodged on the balloon shaft.No patient complications were reported.
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 2.25 x 20mm stent delivery system was returned for analysis.A visual and microscopic examination of the stent found stent damage, with stent struts lifted and stretched along the entire length of the stent.The stent had moved proximally on the device, past the balloon cones, with the proximal stent located now 5.5cm distal to the port bond.The balloon cones were reviewed and no issues were noted.The balloon wings were not subjected to positive pressure.In the absence of the stent, which had moved off the balloon, visible crimp markings were evident on the balloon.A visual and microscopic examination of the bumper tip found distal tip damage.A visual and tactile examination of the hypotube found multiple hypotube kinks at several locations along the length of the hypotube.A visual examination of the outer and inner lumen and mid-shaft section found the damaged stent was now located 5.5cm distal to the port bond, no other issues were noted along the shaft polymer extrusion.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the proximal circumflex artery.After ablation was performed using a 1.5mm rotaburr a 3.0 x 20 synergy drug-eluting stent (des) was placed.A 2.25 x 20 synergy des was advanced but failed to cross the lesion, when trying to enter the proximal part of the guidezilla the stent was dislodged, this was not noticed until later.After examining the stent delivery system dislodged stent was found on the stent delivery shaft.No patient complication were reported.It was further reported that the stent also failed to pass through guidezilla and dislodged.

• 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: 8618043
• Report Number: 2134265-2019-05399
• Device Sequence Number: 13971736
• Product Code: NIQ
• UDI-Device Identifier: 08714729840145
• UDI-Public: 08714729840145
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/17/2019

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 Expiration Date: 09/12/2020
• Device Model Number: 10603
• Device Catalogue Number: 10603
• Device Lot Number: 0022670770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR