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

Model Number 26929

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2019

Event Type  Injury  

Event Description

It was reported that stent elongation occurred resulting in patient surgery.An innova (5x120x130cm) self expanding stent was selected for treatment in a lower extremity peripheral angiogram procedure.The innova stent was placed in the distal right superficial femoral artery (sfa) without any noted resistance during deployment.The physician used the pull grip to complete the deployment process and started to retract the stent delivery system back on the 0.035 guidewire and through the 6f non-bsc sheath.The innova stent was observed to be stretched when the device was retracted through the 6f non-bsc sheath which was located in the in the left common femoral artery (cfa) extending into the proximal right sfa.The stent delivery system was fully removed from that patient.The 0.035 guidewire remained in place through the entire right sfa.It appeared that 40mm of the stent was deployed normally in the distal sfa before the stent began to stretch back ending with the proximal end of the stent being 80mm in the sheath.The physician estimated that the stent stretched about 300mm its entirety.The physician was not able to get the stent out of the sheath.The patient was in stable condition.The physician elected to take the patient to surgery.The outcome and the patient's condition post surgery was unknown at the time of reporting.

Manufacturer Narrative

Updated information to b3 date of event.It was originally reported that the event date was (b)(6) 2019 however through additional information on the medwatch report the event date was corrected to (b)(6) 2019.

Event Description

It was reported that stent elongation occurred resulting in patient surgery.An innova (5x120x130cm) self expanding stent was selected for treatment in a lower extremity peripheral angiogram procedure.The innova stent was placed in the distal right superficial femoral artery (sfa) without any noted resistance during deployment.The physician used the pull grip to complete the deployment process and started to retract the stent delivery system back on the 0.035 guidewire and through the 6f non-bsc sheath.The innova stent was observed to be stretched when the device was retracted through the 6f non-bsc sheath which was located in the in the left common femoral artery (cfa) extending into the proximal right sfa.The stent delivery system was fully removed from that patient.The 0.035 guidewire remained in place through the entire right sfa.It appeared that 40mm of the stent was deployed normally in the distal sfa before the stent began to stretch back ending with the proximal end of the stent being 80mm in the sheath.The physician estimated that the stent stretched about 300mm its entirety.The physician was not able to get the stent out of the sheath.The patient was in stable condition.The physician elected to take the patient to surgery.The outcome and the patient's condition post surgery was unknown at the time of reporting.It was further reported via voluntary medwatch mw5089127 that the stent deployed into the distal end of the sheath due to a delivery system malfunction.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8962221
• MDR Text Key: 156797796
• Report Number: 2134265-2019-10554
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873945
• UDI-Public: 08714729873945
• Combination Product (y/n): N
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0022792154
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 09/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention