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

Lot Number 0031091705

Device Problems Difficult to Remove (1528); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Additional information reported via medwatch (b)(4).

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 321384547
• Report Number: 2124215-2023-40262
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981060
• UDI-Public: 08714729981060
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/16/2023
• Supplement Dates Manufacturer Received: 08/11/2023; 09/15/2023
• Supplement Dates FDA Received: 09/05/2023; 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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