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

Model Number 26926

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: (b)(6).

Event Description

It was reported that the stent jumped forward and elongated.The 90% stenosed target lesion was located in the highly calcified and normally tortuous left common iliac and external iliac arteries.An ipsilateral approach was used to access the lesion.A bsc 6f super sheath was used for access and a non-bsc wire was selected.Pre-dilation was performed with a 5mm balloon, however, pre-dilation did not open the lesion large enough.A 7 x 150 x 130 innova vascular stent was selected for use within the left common iliac to the distal portion of the external iliac artery.During deployment, the stent jumped forward and elongated.When beginning to deploy, the stent moved forward through a high grade stenosis of the left common iliac.The stent deployed without issue for 30-40mm, but then once the stent hit the high grade stenosis it elongated for about 30mm before returning back to looking normal and not elongated.No stent fracture was noted.Due to the elongation, the end of the stent completed deployment within the sheath.By pulling the sheath back a few millimeters, the stent was able to deploy and properly expand inside of the common femoral artery.The procedure was completed by performing a planned post dilation of the stent.No patient complications were reported.

Event Description

It was reported that the stent jumped forward and elongated.The 90% stenosed target lesion was located in the highly calcified and normally tortuous left common iliac and external iliac arteries.An ipsilateral approach was used to access the lesion.A bsc 6f super sheath was used for access and a non-bsc wire was selected.Pre-dilation was performed with a 5mm balloon, however, pre-dilation did not open the lesion large enough.A 7 x 150 x 130 innova vascular stent was selected for use within the left common iliac to the distal portion of the external iliac artery.During deployment, the stent jumped forward and elongated.When beginning to deploy, the stent moved forward through a high grade stenosis of the left common iliac.The stent deployed without issue for 30-40mm, but then once the stent hit the high grade stenosis it elongated for about 30mm before returning back to looking normal and not elongated.No stent facture was noted.Due to the elongation, the end of the stent completed deployment within the sheath.By pulling the sheath back a few millimeters, the stent was able to deploy and properly expand inside of the common femoral artery.The procedure was completed by performing a planned post dilation of the stent.No patient complications were reported.

Manufacturer Narrative

A2: age at time of event: 78 years old device evaluated by mfr: the complaint device was not received at the complaint investigation site for analysis.A photo provided by the customer showed what appeared to be two implanted stents, but no measurements were provided, so the length of the stent could not be confirmed.The left stent appeared to be under-deployed in the bottom section.Under-deployed stents often are due to the struts hitting a hard surface or calcium.

• 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: 8884016
• MDR Text Key: 153988869
• Report Number: 2134265-2019-09538
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0023517671
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: STIFF GLIDEWIRE BY TERUMO; GUIDEWIRE: STIFF GLIDEWIRE BY TERUMO; GUIDEWIRE: STIFF GLIDEWIRE BY TERUMO