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

Model Number 26921

Device Problems Activation, Positioning or Separation Problem (2906); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2021

Event Type  Injury  

Event Description

It was reported that the stent partially deployed and a dislodgement occurred.After opening the superficial femoral artery, the patient developed a dissection.A 6 x 150 x 130 innova was selected for use.During the procedure, the stent did not fully deploy and there was intravascular drag and stretch.The stent dislodged.A non-boston scientific stent was deployed to cover and overlap the innova stent.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that the stent partially deployed and a dislodgement occurred.After opening the superficial femoral artery, the patient developed a dissection.A 6 x 150 x 130 innova was selected for use.During the procedure, the stent did not fully deploy and there was intravascular drag and stretch.The stent dislodged.A non-boston scientific stent was deployed to cover and overlap the innova stent.There were no patient complications reported and the patient's status was stable.It was further reported that vascular access was obtained via the contralateral common femoral artery, through the common iliac artery, the other common iliac artery, the other common femoral artery, finally reaching the superficial femoral artery (sfa).The more than 95 percent stenosed target lesion was located in the mildly tortuous and moderately calcified sfa.The lesion was pre-dilated.High force was required to turn the thumbwheel.The whole stent deployed; however after deployment, the stent was stretched.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an innova sds.The outer sheath, tip and the remainder of the device were checked for damage.The catheter shaft showed a kink at the nosecone.The middle sheath showed no damage.The inner liner was extended to the maximum position with no damage.The stent was not returned in the device.The pull handle was at its farthest position.X-ray of the device showed no internal damage.No other damage was noticed.Inspection of the remainder of the device, apart from the observed issue, revealed no other issues or irregularities.

Event Description

It was reported that the stent partially deployed and a dislodgement occurred.After opening the superficial femoral artery, the patient developed a dissection.A 6 x 150 x 130 innova was selected for use.During the procedure, the stent did not fully deploy and there was intravascular drag and stretch.The stent dislodged.A non-boston scientific stent was deployed to cover and overlap the innova stent.There were no patient complications reported and the patient's status was stable.It was further reported that vascular access was obtained via the contralateral common femoral artery, through the common iliac artery, the other common iliac artery, the other common femoral artery, finally reaching the superficial femoral artery (sfa).The more than 95 percent stenosed target lesion was located in the mildly tortuous and moderately calcified sfa.The lesion was pre-dilated.High force was required to turn the thumbwheel.The whole stent deployed; however after deployment, the stent was stretched.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12795219
• MDR Text Key: 280691199
• Report Number: 2134265-2021-13905
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

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: 03/04/2024
• Device Model Number: 26921
• Device Catalogue Number: 26921
• Device Lot Number: 0026918105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 12/02/2021
• Supplement Dates FDA Received: 12/01/2021; 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 79 KG