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

Model Number	26926
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent partial deployment occurred.The 75% stenosed target lesion was located in a mildly tortuous and moderately calcified proximal superficial femoral artery.Following the use of the rotablator, a 7 x 150 x 130 cm innova vascular stent system was selected to be deployed in the lesion.The innova was advanced over the rotawire, and the thumbwheel was turned until the white arrow appeared; however, the shaft was unable to be pulled to complete deployment.The wire would not advance or withdraw, and the stent was partially deployed, so the decision was made to separate the white housing and use a pin and pull method of deployment to complete the stent deployment.The original stent was used to complete the procedure and there were no patient complications reported.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14682534
• Report Number: 2134265-2022-06453
• Device Sequence Number: 5617864
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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: 09/02/2026
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0027963561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Unknown
• Patient Weight: 82 KG
• Patient Race: White