MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT

Model Number	10618
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It wa reported that difficulty removal and deflation failure occurred.The target lesion was located in the left anterior descending artery.A 4.50 x 16mm synergy ii drug eluting stent was advanced for treatment.After the stent was deployed in the lesion, the doctor tried to remove the stent balloon but it could not come out of the guiding catheter.The balloon was deflated for about 30 seconds a vacuum was held during removal after the stent would not deflate and was removed partially inflated.The physician remove the guiding catheter, wire and balloon as one unit to get everything out safely and completed the procedure with the same device.There were no patient complications reported.
Event or Problem Description
It wa reported that difficulty removal and deflation failure occurred.The target lesion was located in the left anterior descending artery.A 4.50 x 16mm synergy ii drug eluting stent was advanced for treatment.After the stent was deployed in the lesion, the doctor tried to remove the stent balloon but could not come out of the guiding catheter after the stent would not deflate.So the physician remove the guiding catheter wire and balloon as one unit to get everything out safely and completed the procedure with the same device.There were no patient complications reported.It was further reported that the target lesion was 100% stenosed and was mildly tortuous and mildly calcified.

• Brand Name: SYNERGY
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12650334
• Report Number: 2134265-2021-13042
• Device Sequence Number: 1416669
• Product Code: NIQ
• UDI-Device Identifier: 08714729973355
• UDI-Public: 08714729973355
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003/S039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 02/09/2022
• Device Model Number: 10618
• Device Catalogue Number: 10618
• Device Lot Number: 0025228873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown