MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VENOUS WALLSTENT; STENT, ILIAC VEIN

Model Number	H74912044189070
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The 60% compression stenosed target lesion was located in the moderately tortuous and moderately calcified left common to external iliac vein.A 18x90x75cm venous wallstent was inserted through left common femoral vein over a 0.35 amplatz wire.However, slightly difficulty in advancing the tortuous vessel was encountered.It was noted that the stent was partially deployed and was too short.Recapturing the stent was difficult and had to deploy it and capture it in torturous area to fully recapture.Difficulty removal of the stent was also encountered.Subsequently, it was pulled out successfully intact from the patient.Upon removal of the stent, possible kink was noted with the shaft.Another 18x90x75 venous wallstent was used and completed the procedure successfully.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The 60% compression stenosed target lesion was located in the moderately tortuous and moderately calcified left common to external iliac vein.A 18x90x75cm venous wallstent was inserted through left common femoral vein over a 0.35 amplatz wire.However, slightly difficulty in advancing the tortuous vessel was encountered.It was noted that the stent was partially deployed and was too short.Recapturing the stent was difficult and had to deploy it and capture it in torturous area to fully recapture.Difficulty removal of the stent was also encountered.Subsequently, it was pulled out successfully intact from the patient.Upon removal of the stent, possible kink was noted with the shaft.Another 18x90x75 venous wallstent was used and completed the procedure successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: venous wallstent 18x90x75cm was received for analysis.The device was received with the stent over constrained on the device.The investigator successfully deployed the stent without issue.A visual examination found no damage to the deployed stent.A visual examination identified no damage or issues with the stent holder/cup or tip of the device.A visual and tactile examination found the outer sheath to be partially separated at more than one location.This type of damage is consistent with excessive force being applied to the device.This concludes the product analysis.

• Brand Name: VENOUS WALLSTENT
• Common Device Name: STENT, ILIAC VEIN
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16930195
• Report Number: 2124215-2023-19869
• Device Sequence Number: 7008347
• Product Code: QAN
• UDI-Device Identifier: 08714729979616
• UDI-Public: 08714729979616
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980033/S050
• 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): 06/07/2023

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: 02/27/2025
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Device Lot Number: 0031139002
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - 0.35 AMPLATZ.; GUIDEWIRE - 0.35 AMPLATZ.
• Patient Sex: Unknown