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

Lot Number	0031091705
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation issue and removal difficulties occurred.The target lesion was located in the moderately calcified right coronary artery.A 3.50 x 24mm synergy xd drug-eluting stent was advanced and deployed using a 5f jr4 guide catheter.However, during removal, the balloon would not fully deflate and there was difficulty removing the device from the guide catheter.All interventional equipment was then removed as one unit and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Additional information reported via medwatch (b)(4).
Event or Problem Description
It was reported that deflation issue and removal difficulties occurred.The target lesion was located in the moderately calcified right coronary artery.A 3.50 x 24mm synergy xd drug-eluting stent was advanced and deployed using a 5f jr4 guide catheter.However, during removal, the balloon would not fully deflate and there was difficulty removing the device from the guide catheter.All interventional equipment was then removed as one unit and the procedure was completed.There were no patient complications reported.
Additional Manufacturer Narrative
Additional information reported via medwatch (b)(4).Device evaluated by mfr: device was returned for analysis.Visual, tactile, microscopic, functional and device-to-device interaction analysis was performed on the device.No issues were identified with the hypotube shaft.The shaft polymer had no issues identified with the outer / mid-shaft sections or the inner lumen of the device.The stent was not attached to the balloon.The balloon cones were reviewed, and positive pressure was applied to the balloon and was in a deflated state.Bumper tip showed no signs of distal tip damage.The device was attached to an inflation unit and the balloon was inflated to rated burst pressure, held pressure and deflated without issue.The device could be loaded and tracked with a 5f guide catheter with no issue.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that deflation issue and removal difficulties occurred.The target lesion was located in the moderately calcified right coronary artery.A 3.50 x 24mm synergy xd drug-eluting stent was advanced and deployed using a 5f jr4 guide catheter.However, during removal, the balloon would not fully deflate and there was difficulty removing the device from the guide catheter.All interventional equipment was then removed as one unit and the procedure was completed.There were no patient complications reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17560102
• Report Number: 2124215-2023-40262
• Device Sequence Number: 19733094
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: 08714729981060
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup
• Report Date (Section B): 10/11/2023

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: 02/06/2025
• Device Lot Number: 0031091705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 09/15/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/05/2023; 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER USED: 5F JR4 GUIDE; GUIDE CATHETER USED: 5F JR4 GUIDE; GUIDE CATHETER USED: 5F JR4 GUIDE
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: White