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

Lot Number	0030852387
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.25 x 28mm synergy xd drug-eluting stent was advanced into the patient for treatment; however, the physician could not locate the stent anywhere.It was then found out that the stent was still in the protective covering and had been removed from the stent balloon.The procedure was completed with another stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 2.25 x 28mm stent delivery system was returned for analysis.Visual and tactile examination of the stent noted damage.Microscopic analysis revealed te stent was returned attached to the product mandrel with bunching noted at the distal section.Visual and tactile examination of the hypotube shaft noted multiple hypotube kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis of the bumper tip showed no signs of distal tip damage.The balloon cones were reviewed, and no issues were noted.The device was returned attached to the product mandrel and therefore a stent outer diameter (od) could not be obtained.The stent od at the time of manufacturing was within maximum crimped stent profile measurement as per specification.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.A 2.25 x 28mm synergy xd drug-eluting stent was advanced into the patient for treatment; however, the physician could not locate the stent anywhere.It was then found out that the stent was still in the protective covering and had been removed from the stent balloon.The procedure was completed with another stent.No patient complications 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: 19983981
• Report Number: 2124215-2024-49004
• Device Sequence Number: 7201295
• Product Code: NIQ
• UDI-Device Identifier: 08714729980759
• UDI-Public: 08714729980759
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 01/08/2025
• Device Lot Number: 0030852387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2023
• 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
• Patient Sex: Unknown