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

Lot Number	0031348656
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment in a moderately tortuous vessel.However, during procedure, the device was not able to cross the lesion and removal difficulty was also noted.The procedure was completed with no patient complications nor injuries reported.
Additional Manufacturer Narrative
The returned product consisted of the synergy xd mr us 3.00 x 12 mm.Stent delivery system.Visual, tactile and microscopic and device-to-device interaction testing was performed on the device.A guidewire could pass through the device without issue.A hypotube break was noted 21.7 cm.Distal to the distal end of the strain relief and a hypotube kink was located 117.4 cm.From tip of device.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that removal difficulty occurred.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment in a moderately tortuous vessel.However, during procedure, the device was not able to cross the lesion and removal difficulty was also noted.The procedure was completed with no patient complications nor injuries 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17792375
• Report Number: 2124215-2023-48270
• Device Sequence Number: 7750451
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): Y
• 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): 10/31/2023

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: 03/20/2025
• Device Lot Number: 0031348656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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