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

Lot Number 0029640478

Device Problems Entrapment of Device (1212); Material Deformation (2976)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that the entrapment of the device occurred.The target lesion was located in the left anterior descending (lad) artery.The physician used a non-boston scientific guidewire pressure to the lesion.A 2.75 x 38mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stuck into the guidewire and could not be advanced nor removed.As it was tried to removed from the wire, the stent was deformed.Both devices were removed as one unit.The procedure was completed with a non-boston scientific device.There were no patient complications reported.

Event Description

It was reported that the entrapment of the device occurred.The target lesion was located in the left anterior descending (lad) artery.The physician used a non-boston scientific guidewire pressure to the lesion.A 2.75 x 38mm synergy xd drug-eluting stent was advanced to treat the lesion.However, during the procedure, the stent was stuck into the guidewire and could not be advanced nor removed.As it was tried to removed from the wire, the stent was deformed.Both devices were removed as one unit.The procedure was completed with a non-boston scientific device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: synergy xd mr us 2.75 x 38mm, catheter was returned for analysis.The device was returned to the cis for analysis.A visual, tactile, microscopic and device to device interaction test was performed.An examination of the returned device identified that the extrusion was stretched and accordioned.As a result of the extrusion damage, the extrusion was stretched down onto the 0.014inch size wire (guidewire measured using a snap gauge at 0.014inch).As a result, it was not possible to remove the guidewire from the device.A microscopic examination of the crimped stent identified that the proximal to mid section of the crimped stent was bunched with stent struts misaligned.No other damages were present along the device.

• 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: 18969369
• MDR Text Key: 338689189
• Report Number: 2124215-2024-17430
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729980933
• UDI-Public: 08714729980933
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0029640478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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
• Treatment: GUIDEWIRE: PHILLIPS OMNIWIRE 0.014; GUIDEWIRE: PHILLIPS OMNIWIRE 0.014