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

Model Number	10605
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us mr 3.00 x 28mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage.The struts on the distal end lifted and pulled distally.The undamaged crimped stent outer diameter was measured and the result is 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 examination of the bumper tip showed signs of damage.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.Device tracked without issues on a test guidewire.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 04-feb-2021.It was reported via voluntary medwatch/maude report #: (b)(4) that guidewire loading difficulty and tip damage occurred.Post transcatheter aortic valve replacement, the patient presented to the emergency department with chest pain and non-st elevation myocardial infarction.When a 3.00 x 28mm synergy ii drug-eluting stent was opened, tip was damaged and unable to load into the wire.The procedure was completed with another of the same device and no patient complications were reported.However, returned device analysis revealed stent damage.

• 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: 11368624
• Report Number: 2134265-2021-01525
• Device Sequence Number: 13731258
• Product Code: NIQ
• UDI-Device Identifier: 08714729840299
• UDI-Public: 08714729840299
• Combination Product (Y/N): Y
• 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
• Report Date (Section B): 02/23/2021

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: 11/18/2021
• Device Model Number: 10605
• Device Catalogue Number: 10605
• Device Lot Number: 0024833028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR