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

Medical Device Problem Codes	Entrapment of Device (1212); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem 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
• 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: 19075806
• Report Number: 2124215-2024-20350
• Device Sequence Number: 11926670
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Race: White