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

Model Number	10607
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in the mildly calcified left anterior descending artery.A 4.00 x 38 synergy drug-eluting stent was advanced but failed to cross the lesion.A guide extension catheter was added but still it failed to cross the lesion.The device was tried to pull back inside the guide catheter and was unsuccessful even after multiple attempts.Then, it was tried to pull the wire, guide and stent back through the sheath but was also unsuccessful.A second sheath was started in the right femoral artery, just distal to the 1st sheath.The device was completely removed from the patient's body by a snare and out of the second sheath that was started.The procedure was completed with a new 4x38 synergy stent and no patient complications were reported.

• 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: 10844634
• Report Number: 2134265-2020-15751
• Device Sequence Number: 17051446
• Product Code: NIQ
• UDI-Device Identifier: 08714729840435
• UDI-Public: 08714729840435
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 11/16/2020

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: 01/01/2022
• Device Model Number: 10607
• Device Catalogue Number: 10607
• Device Lot Number: 0024998257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/16/2020
• 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
• Patient Age: 37 YR