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

Model Number	26924
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent started to deploy before entering the body.A 8 x 80 x 130 innova self-expanding stent was selected for a bilateral external iliac stenting procedure.The sent was inadvertently deployed prior to entering the patient.There were no patient complications reported and the procedure was completed with another stent.
Additional Manufacturer Narrative
Device eval.By manufacturer: the returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was partially deployed 17mm from the sheath.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock was still in the manufactured position.A test guidewire was inserted into the device and was able to pass through, with some resistance, at the kinked section.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis confirmed the stent is partially outside of the sheath.
Event or Problem Description
It was reported that the stent started to deploy before entering the body.A 8 x 80 x 130 innova self-expanding stent was selected for a bilateral external iliac stenting procedure.The sent was inadvertently deployed prior to entering the patient.There were no patient complications reported and the procedure was completed with another stent.

• 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: 12573458
• Report Number: 2134265-2021-12372
• Device Sequence Number: 16374753
• Product Code: NIP
• UDI-Device Identifier: 08714729874195
• UDI-Public: 08714729874195
• 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
• 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): 11/18/2021

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: 06/20/2026
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0027526905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male