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

Model Number	10614
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy ii us otw 2.25 x 32 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent struts in the mid-section of the stent were lifted and misaligned.The undamaged crimped stent outer diameter was measured and the result 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 and microscopic examination of the tip showed no signs of damage.A visual and tactile examination of the outer and mid-shaft section and visual examination of the inner lumen found no issues with the extrusion shaft.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 13may2021.It was reported that crossing difficulty occurred.Following pre-dilation, a 2.25 x 32 synergy drug-eluting stent was advanced but failed to cross the lesion.No patient complications were reported and the patient status was stable.However, returned device analysis revealed stent damaged.

• 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: 11930663
• Report Number: 2134265-2021-07192
• Device Sequence Number: 4381144
• Product Code: NIQ
• UDI-Device Identifier: 08714729840800
• UDI-Public: 08714729840800
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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: 03/25/2021
• Device Model Number: 10614
• Device Catalogue Number: 10614
• Device Lot Number: 0023568951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PREDILATING BALLOON: 2.25 X 30 EMERGE OTW