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

Model Number	10601
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	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is a combination product.Device evaluated by mfr.: synergy ii us mr 4.00mm x 12mm stent delivery system was returned for analysis.The device was returned with no stent attached.A review of the manufacturing stent profile data was performed and the max stent outer diameter, of all stents at the time of manufacture is within max 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.Examination of the tip identified tip damage.Examination of the hypotube found multiple hypotube kinks.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 04mar2021.It was reported that crossing difficulty occurred.A 4.00 x 12 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 that delivery system was retuned without a stent.

• 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: 11574126
• Report Number: 2134265-2021-03935
• Device Sequence Number: 3521360
• Product Code: NIQ
• UDI-Device Identifier: 08714729840077
• UDI-Public: 08714729840077
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 10/06/2021
• Device Model Number: 10601
• Device Catalogue Number: 10601
• Device Lot Number: 0024595277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1