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

Lot Number 0030824806

Device Problems Entrapment of Device (1212); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

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

Event Date 01/08/2024

Event Type  malfunction  

Event Description

It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.Following pre-dilation using a scoring balloon, a 3.00 x 32mm synergy xd drug-eluting (des) stent was introduced for treatment.However, when the physician tried to advance and deliver the stent, the stent dislodged and got stuck at the proximal part of a non-bsc guide catheter.The guide catheter and the stent were removed as one unit.A new guide catheter and a new 3.00 x 32 synergy xd des were then used, and the procedure was completed successfully.No patient complications were reported.

Manufacturer Narrative

The device was not returned for analysis; therefore, a technical analysis could not be performed.An image of the detached stent provided by the site was examined by boston scientific personnel.The stent was stretched and damaged.This damage likely occurred during the retrieval from the guide.

Event Description

It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.Following pre-dilation using a scoring balloon, a 3.00 x 32mm synergy xd drug-eluting (des) stent was introduced for treatment.However, when the physician tried to advance and deliver the stent, the stent dislodged and got stuck at the proximal part of a non-bsc guide catheter.The guide catheter and the stent were removed as (b)(4) unit.A new guide catheter and a new 3.00 x 32 synergy xd des were then used, and the procedure was completed successfully.No patient complications 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: 18606247
• MDR Text Key: 334096291
• Report Number: 2124215-2024-03062
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: 0030824806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: Asian