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

Model Number	H74912044189070
Medical Device Problem Codes	Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that difficulty positioning occurred.Patient underwent a venogram procedure where the physician obtained venous access and did an initial intervascular ultrasound run.The target was a compression located in the non-tortuous and non-calcified common femoral artery.An 18x90x75cm venous wallstent was implanted, but it was noted that the distal tip was not expanding.An 18-6/5.8/75 xxl esophageal balloon dilator was advanced for dilation, but it would not track through the distal portion of the stent.A smaller 035 non-boston scientific balloon was switched which successfully tracked and expanded.The flow post-stent was unsatisfactory after shooting contrast on fluoroscopy.The physician made further access by first inserting the non-bsc balloon followed by the xxl balloon.After the first inflation, the xxl balloon ruptured.Inflation was quick, up and down, and was estimated to be under 30 seconds.The device was removed and replaced by a different model to complete the procedure.The wallstent fully expanded in which the case ended with a good flow.The stent struts were assumed to be stuck together, but after reviewing post-case, they may have initially stuck and stented the tip of the great saphenous vein instead of the common femoral artery in which it popped from the tip when post-ballooning.There were no complications reported, and patient status was stable.
Additional Manufacturer Narrative
B5.Describe event or problem: updated common femoral artery to common femoral vein.
Event or Problem Description
It was reported that difficulty positioning occurred.Patient underwent a venogram procedure where the physician obtained venous access and did an initial intervascular ultrasound run.The target was a compression located in the non-tortuous and non-calcified common femoral vein.An 18x90x75cm venous wallstent was implanted, but it was noted that the distal tip was not expanding.An 18-6/5.8/75 xxl esophageal balloon dilator was advanced for dilation, but it would not track through the distal portion of the stent.A smaller 035 non-boston scientific balloon was switched which successfully tracked and expanded.The flow post-stent was unsatisfactory after shooting contrast on fluoroscopy.The physician made further access by first inserting the non-bsc balloon followed by the xxl balloon.After the first inflation, the xxl balloon ruptured.Inflation was quick, up and down, and was estimated to be under 30 seconds.The device was removed and replaced by a different model to complete the procedure.The wallstent fully expanded in which the case ended with a good flow.The stent struts were assumed to be stuck together, but after reviewing post-case, they may have initially stuck and stented the tip of the great saphenous vein instead of the common femoral vein in which it popped from the tip when post-ballooning.There were no complications reported, and patient status was stable.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19014533
• Report Number: 2124215-2024-18555
• Device Sequence Number: 11714699
• Product Code: QAN
• UDI-Device Identifier: 08714729979616
• UDI-Public: 08714729979616
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980033/S050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2026
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Device Lot Number: 0033279086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female