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

Lot Number 0030232248

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 10/09/2023

Event Type  Injury  

Event Description

It was reported that a detachment occurred, resulting in a cancellation.A 2.25 x 20mm synergy xd stent balloon expandable device was selected for use to treat a calcified lesion.During the procedure via subclavian pathway, numerous attempts were made to cross the calcified lesion but difficulty was encountered.When an attempt was made to withdraw the balloon catheter, it was noted that the balloon broke 20 cm before the stent.The stent and a piece of the balloon catheter migrated into the ascending aorta.The procedure was cancelled and rescheduled.During the subsequent procedure via femoral pathway, the piece of catheter was retrieved with a non-bsc snare.Radiation exposure of one gray occurred, but no direct patient consequence was reported.No further information is available.

• 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: 18088506
• MDR Text Key: 327587608
• Report Number: 2124215-2023-61457
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0030232248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Patient Outcome(s): Required Intervention