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

Model Number 26924

Device Problems Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  Injury  

Event Description

It was reported that the stent deployed in an incorrect location.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left common iliac.An 8 x 40 x 130 innova stent was advanced contralaterally over a 0.035 unknown guidewire inside an unknown 8 fr sheath.Stent deployment was initiated.The physician noticed resistance during deployment and attempted to pull the delivery system and sheath back.The stent was deployed 2cm and started to come back as well.The stent came across the bifurcation and deployed itself in the right common iliac.The physician gained access on the left side and placed another 8 x 40 x 130 innova stent to complete the procedure.The stent in the right iliac remained.There were no patient complications and the patient status was fine post procedure.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8842095
• MDR Text Key: 152671597
• Report Number: 2134265-2019-08895
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention