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

Model Number	H7493941820500
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	06/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation failure occurred.The 80%stenosed target lesion was located in the non tortuous and non calcified saphenous vein graft.A 5.00 x 20mm synergy xd drug-eluting stent was deployed at nominal pressure for treatment.Post stent deployment, it was observed that the balloon did not deflate properly and the balloon did not rewrap.After the balloon was deflated for one minute, an attempt was made to remove the balloon but it would not go back into the 6 fr guide catheter.An indeflator was attached and pulled negative pressure several times and the balloon was finally pulled back into the guide catheter and removed in partially inflated state to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a synergy xd mr ous us 5.00 x 20mm stent delivery system was returned for analysis without the stent.An examination of the crimped stent found that the stent was not returned for analysis as it was successfully deployed at the lesion site.The balloon was reviewed, and it appeared to be in a deflated state with signs of positive pressure being applied to its cones noted.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.The device was soaked overnight in a water bath at 37 degrees.The device was tracked without issues on a 0.0140 test guidewire and loaded without issues on a 6f test guidecatheter.An inflation/deflation test was performed using an encore device verified with a druck gauge to 16 atmospheres and the device inflated, maintained pressure, and deflated within 26 seconds as per instructions for use.No leaks, loss of pressure or any other damage was noted on the balloon.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that deflation failure occurred.The 80%stenosed target lesion was located in the non tortuous and non calcified saphenous vein graft.A 5.00 x 20mm synergy xd drug-eluting stent was deployed at nominal pressure for treatment.Post stent deployment, it was observed that the balloon did not deflate properly and the balloon did not rewrap.After the balloon was deflated for one minute, an attempt was made to remove the balloon but it would not go back into the 6 fr guide catheter.An indeflator was attached and pulled negative pressure several times and the balloon was finally pulled back into the guide catheter and removed in partially inflated state to complete the procedure.There were no patient complications reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12105173
• Report Number: 2134265-2021-08456
• Device Sequence Number: 17288284
• Product Code: NIQ
• UDI-Device Identifier: 08714729981268
• UDI-Public: 08714729981268
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 06/22/2022
• Device Model Number: H7493941820500
• Device Lot Number: 0025648746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR