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

Model Number 26920

Device Problem Premature Activation (1484)

Patient Problem No Patient Involvement (2645)

Event Date 03/17/2019

Event Type  malfunction  

Event Description

It was reported that the stent was found partially deployed inside of the packaging.A 6x60x75 innova self expanding stent was selected for a patient procedure.During preparation outside of the patient, the stent was found partly deployed in the package.The device was not used for the procedure.No patient complications were reported.

Manufacturer Narrative

The device was not returned for analysis, therefore a failure analysis of the complaint device could not be completed.The customer provided a photo of the distal portion of the device.The photo was reviewed, and it appears that the device was taken out of the packaging.It can be seen that the stent is partially deployed.The inner liner appears to have fluid in it because there is a significant difference in the color at two locations in the photo.Fluids usually enter the device when it is being prepped/flushed with saline or when the device is advanced into a patient and blood enters the device.The location of the distal end of the middle sheath is fairly proximal that it is no longer in contact with the proximal end of the tip which indicates that the thumbwheel was used.The dfu list a precaution stating,''premature removal of the thumbwheel lock may result in an unintended deployment of the stent''.It appears the stent may have been unintentionally deployed by the user.The device was then returned for analysis on 17, may 2019.Device evaluated by mfr: 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.When reviewing the photos provided by the customer, the device appears to be in a similar condition when received.Visual examination revealed that the stent is partially deployed 11mm from the distal end of the middle sheath.There is a kink at the nosecone and another kink to the inner liner 21mm from the tip.The kink at the inner liner is not visible in the photo provided by the customer so it is likely that this damage occurred when the device was sent back for analysis.The yellow thumbwheel lock is still in the manufactured position.From the handle to the knob on the rack is approximately 10mm.The middle sheath is no longer sitting on top of the proximal end of the tip and the rack is no longer in the manufactured position which indicates that the lock was off at one point.Microscopic examination revealed no additional damages.There is blood present in the inner liner and on the tip.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink at the nosecone and inner liner were attributable to handling.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the stent was found partially deployed inside of the packaging.A 6x60x75 innova self expanding stent was selected for a patient procedure.During preparation outside of the patient, the stent was found partly deployed in the package.The device was not used for the procedure.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was not returned for analysis, therefore a failure analysis of the complaint device could not be completed.The customer provided a photo of the distal portion of the device.The photo was reviewed, and it appears that the device was taken out of the packaging.It can be seen that the stent is partially deployed.The inner liner appears to have fluid in it because there is a significant difference in the color at two locations in the photo.Fluids usually enter the device when it is being prepped/flushed with saline or when the device is advanced into a patient and blood enters the device.The location of the distal end of the middle sheath is fairly proximal that it is no longer in contact with the proximal end of the tip which indicates that the thumbwheel was used.The dfu list a precaution stating,''premature removal of the thumbwheel lock may result in an unintended deployment of the stent''.It appears the stent may have been unintentionally deployed by the user.

Event Description

It was reported that the stent was found partially deployed inside of the packaging.A 6 x 60 x 75 innova self expanding stent was selected for a patient procedure.During preparation outside of the patient, the stent was found partly deployed in the package.The device was not used for the procedure.No patient complications were reported.

• Brand Name: INNOVA
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8520418
• MDR Text Key: 142197658
• Report Number: 2134265-2019-03868
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0022901339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1