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

Device Problems Entrapment of Device (1212); Activation Failure (3270)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/14/2024

Event Type  Injury  

Event Description

It was reported that insufficient apposition, catheter entrapment, and unretrieved device fragment occurred requiring additional intervention.The patient underwent angioplasty in the severely calcified right coronary artery (rca) using an opticross hd 5fr catheter before stent implantation.Pre-dilatation was performed with a 3.0 emerge balloon catheter, followed by a 3.0 x 6 wolverine balloon catheter.A 3.0 x 16mm and 3.5 x 16mm synergy drug-eluting stent (des) were deployed, respectively, from distal to proximal lesion.The doctor attempted to deploy a 4.0 x 20mm synergy at the proximal lesion, guided by ivus indicating a vessel diameter of 3.0 to 5.0 distal to proximal.However, during stent deployment, the physician did not get good expansion with the stent balloon.The balloon was deflated, and when the physician attempted to remove the stent balloon, it became stuck on the stent in an area that was still tight and had not been expanded well.A non-boston scientific guide extension catheter was used, and due to multiple back-and-forth movements with the guide extension catheter, it caused the balloon to shear off from the catheter.They attempted to get a non-boston scientific wire past the balloon stuck inside the stent which was unsuccessful.Next, an attempt to trap the balloon inside the guide and bring it back was performed, but that didn't work.The physician tried different wires, none of which worked, and even attempted to snare the balloon which also failed.After many different attempts to retrieve the detached portion, it was decided to consider additional surgery.Additional non-surgical removal of the balloon will be performed and if it is still unsuccessful, the need for surgery will be considered.At the end of the procedure, the stent balloon remained stuck in the proximal part of the rca with an under-deployed stent.No further issues were 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: 19075806
• MDR Text Key: 339777367
• Report Number: 2124215-2024-20350
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• 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
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White