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

Lot Number	0029640478
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• 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: 18969369
• Report Number: 2124215-2024-17430
• Device Sequence Number: 20403269
• Product Code: NIQ
• UDI-Device Identifier: 08714729980933
• UDI-Public: 08714729980933
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2024
• Device Lot Number: 0029640478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: PHILLIPS OMNIWIRE 0.014; GUIDEWIRE: PHILLIPS OMNIWIRE 0.014
• Patient Sex: Unknown