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

Model Number	10601
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is a combination product.
Event or Problem Description
It was reported that stent dislodged inside patient.A percutaneous coronary intervention was being performed.The target lesion was located in the proximal/ostial right coronary artery.Started with wiring a choice floppy wire and then used a non bsc catheter to exchange for a rota floppy wire.Used a 1.5mm rotablator burr and then exchanged the wire back to the choice floppy wire using the non bsc catheter.A 2.5 x 10 wolverine cutting balloon was used to pre dilated the entire right coronary artery vessel.They successfully placed a 2.75 x 28 synergy drug eluting stent and then overlapped with a 3.0 x 32 synergy drug eluting stent.A mr 3.00 x 12 synergy drug eluting stent was attempted to deliver.However, it failed to get deliver to the proximal/ostial portion of the right coronary artery.After several attempts to push it down, the stent was attempted to be removed and the proximal edge caught on the 6f non bsc guide catheter and striped off.The stent remained on the wire, but in the aorta.Utilizing several balloons, first a 1.0 x 10 non bsc balloon, then a 2.0 x 12 emerge mr, and finally a 3.0 x 12 nc emerge balloon, the stent was pulled down to the distal part of the femoral sheath.A vascular surgeon came into the room and removed the stent successfully from the patient's groin.

• 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: 9825325
• Report Number: 2134265-2020-02769
• Device Sequence Number: 11522380
• Product Code: NIQ
• UDI-Device Identifier: 08714729840053
• UDI-Public: 08714729840053
• 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
• Report Date (Section B): 03/12/2020

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: 10/06/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024606454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/12/2020
• 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