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

Model Number 26920

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

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

Event Date 07/19/2018

Event Type  malfunction  

Event Description

It was reported that the stent partially deployed.A 6x150x130 innova stent was selected for use to treat an in-stent occlusion (unknown manufacturer) in the right proximal and mid superficial femoral artery (sfa).After pre-dilatation, the stent was advanced over an unknown guidewire and the physician attempted to deploy the stent using the thumbwheel.The deployment system suddenly stopped and the thumbwheel became stuck while the stent was partially deployed.The physician then broke apart the deployment handle and performed manual deployment.The stent was dragged partially deployed about 3cm in the sfa, however, the physician was able to manually deploy the rest of the stent.There were no patient complications reported and the patient's condition post procedure was stable.No further intervention was required.

Event Description

It was reported that the stent partially deployed.A 6x150x130 innova stent was selected for use to treat an in-stent occlusion (unknown manufacturer) in the right proximal and mid superficial femoral artery (sfa).After pre-dilatation, the stent was advanced over an unknown guidewire and the physician attempted to deploy the stent using the thumbwheel.The deployment system suddenly stopped and the thumbwheel became stuck while the stent was partially deployed.The physician then broke apart the deployment handle and performed manual deployment.The stent was dragged partially deployed about 3cm in the sfa, however, the physician was able to manually deploy the rest of the stent.There were no patient complications reported and the patient's condition post procedure was stable.No further intervention was required.It was further reported that an amplatz ss 260cm guidewire was used during the procedure.Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds).The stent was not returned.Visual examination showed that the handle was opened upon return from the customer site.There was a kink on the mid-shaft at the retainer clip.There was a kink on the inner liner at the retainer clip.The yellow thumbwheel lock was returned with the device.No damage was noticed on the thumbwheel teeth or the pull rack teeth.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Upon further investigation, the customer may not have known to pull the pull rack at 120mm.If the rack was not pulled at 120mm the remainder of the stent would not deploy, which gave the indication to the customer that there was an issue with the device.The customer opened the device to completely deploy the stent.

• Brand Name: INNOVA
• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7802868
• MDR Text Key: 117792820
• Report Number: 2134265-2018-60208
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2021
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0022122597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• 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 Age: 70 YR
• Patient Weight: 80