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

Model Number 26920

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

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.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.There is blood in the middle sheath.

Event Description

It was reported that the stent jumped during deployment.The 50% stenosed target lesion was located in the moderately calcified straight iliac artery.The vessel diameter was 6 to 7mm.An antegrade approach was used to access the lesion.A non-bsc sheath and non-bsc 0.035 guidewire were used.Pre-dilation was performed.A 7x60x130 innova and an 8x60x130 innova were selected for use.Both stents jumped forward upon initiating deployment.Both stents were able to be fully deployed using the thumbwheel without damaging the stent.The stent implant locations were more forward than planned.The procedure was completed by placing a third stent to cover the intended location.No patient complications were reported.

Manufacturer Narrative

Evaluation conclusion codes corrected from 50 to 61.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.Visual examination revealed a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.There is blood in the middle sheath.

Event Description

It was reported that the stent jumped during deployment.The 50% stenosed target lesion was located in the moderately calcified straight iliac artery.The vessel diameter was 6 to 7mm.An antegrade approach was used to access the lesion.A non-bsc sheath and non-bsc 0.035 guidewire were used.Pre-dilation was performed.A 7x60x130 innova and an 8x60x130 innova were selected for use.Both stents jumped forward upon initiating deployment.Both stents were able to be fully deployed using the thumbwheel without damaging the stent.The stent implant locations were more forward than planned.The procedure was completed by placing a third stent to cover the intended location.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: 8899383
• MDR Text Key: 154542298
• Report Number: 2134265-2019-09310
• 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
• Report Date: 09/10/2019

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: 05/06/2022
• Device Model Number: 26920
• Device Catalogue Number: 26920
• Device Lot Number: 0023750721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: TERUMO GLIDEWIRE ADVANTAGE 0.035; GUIDEWIRE: TERUMO GLIDEWIRE ADVANTAGE 0.035; SHEATH: SHORT TERUMO; SHEATH: SHORT TERUMO
• Patient Outcome(s): Required Intervention