MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	26926
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that labeling issue occurred.The patient was being treated for peripheral arterial disease in the lower extremity.The target lesion was located in the superficial femoral artery.A 5 x 150 x 130 innova vascular stent was selected for treatment.However, a 5 x 120 x 130 innova vascular was found inside the device packaging and it was noted during deployment after the package was scanned by clinical staff monitoring the case.The stent was implanted, and the procedure was completed.It was noted that the target lesion was sufficiently covered, as multiple stents were already planned to be used.No patient complications were reported.
Additional Manufacturer Narrative
Device was implanted inside the patient and will not be returned for analysis.However, an analysis was concluded based on the received photo of the complaint device.It was noticed that the two photos that were sent back have different upn numbers and different batch numbers.There is no indication of a label issue during the manufacturing timeframe with the device due to the manufacturing dates of the device were approximately 6 months apart from each other.
Event or Problem Description
It was reported that labeling issue occurred.The patient was being treated for peripheral arterial disease in the lower extremity.The target lesion was located in the superficial femoral artery.A 5 x 150 x 130 innova vascular stent was selected for treatment.However, a 5 x 120 x 130 innova vascular was found inside the device packaging and it was noted during deployment after the package was scanned by clinical staff monitoring the case.The stent was implanted, and the procedure was completed.It was noted that the target lesion was sufficiently covered, as multiple stents were already planned to be used.No patient complications were reported.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18912472
• Report Number: 2124215-2024-11222
• Device Sequence Number: 17865548
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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 Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0029385816
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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
• Patient Sex: Unknown