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

Model Number	10605
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
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	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left circumflex artery.A 2.25 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent came off the catheter and was crushed against the wall of the proximal circumflex artery.An attempt was made to remove the dislodged stent using the small 1.5 balloon but failed to retrieved due to the angulation into the circumflex.Since there was already a stent deployed in the proximal stent and the distal end of the dislodged stent was stuck in the side cell of that stent as it entered into the side branch, it was decided to leave the stent and compress it into the wall of the vessel.The procedure was completed with no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the left circumflex artery.A 2.25 x 28 synergy drug-eluting stent was advanced for treatment.However, the stent came off the catheter and was crushed against the wall of the proximal circumflex artery.An attempt was made to remove the dislodged stent using the small 1.5 balloon but failed to retrieved due to the angulation into the circumflex.Since there was already a stent deployed in the proximal stent and the distal end of the dislodged stent was stuck in the side cell of that stent as it entered into the side branch, it was decided to leave the stent and compress it into the wall of the vessel.The procedure was completed with no patient complications reported.It was further reported that the target lesion had 80% stenosis, was located in the moderately tortuous and mildly calcified vessel with 80-90 degrees bend.Pre-dilatation was performed.Stent struts became wedged when passing through side cells of previous stent as physician's assessment on the cause of the stent dislodgement.
Additional Manufacturer Narrative
Updated b5: describe event or problem.

• 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: 11156591
• Report Number: 2134265-2020-18778
• Device Sequence Number: 2590205
• Product Code: NIQ
• UDI-Device Identifier: 08714729840268
• UDI-Public: 08714729840268
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: 03/03/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0023463571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/17/2021
• 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
• Patient Age: 60 YR