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

Lot Number 0032293361

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

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

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported that stent dislodgement occurred requiring an additional device.A 4.50 x 12mm synergy xd stent balloon expandable was selected for percutaneous coronary intervention procedure.The target lesion was located distally to the mid right coronary artery (rca).During the procedure, it was noted that a 4.50 x 12mm synergy xd stent would not deliver around the tortuous proximal vessel, so while retrieving, it caught on the tip of the guidezilla guide extension catheter and the stent completely dislodged off the balloon.Physician managed to inflate and deploy this dislodged stent in the proximal vessel in a non-diseased section of the rca.A non bsc 4.0x 12 stent was then successfully delivered to cover the distal lesion, via the same guidezilla guide extension catheter.In the same procedure, physician attempted again with another a 4.50x 12mm synergy xd and delivery was not successful, as upon retrieval the new device again was caught on the tip of the guidezilla guide extension catheter and the stent completely dislodged off the balloon.The physician managed to inflate and deploy this dislodged stent in the proximally rca, which covered a gap between the first two stents.The procedure was completed and the patient was fine and fully recovered.

• 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: 18952528
• MDR Text Key: 338269796
• Report Number: 2124215-2024-16370
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0032293361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• 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
• Patient Outcome(s): Required Intervention