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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26921
Device Problems Positioning Problem (3009); Migration (4003)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 11/19/2019
Event Type  Injury  
Event Description
It was reported that the stent was not deployed in the targeted position.The severely stenosed target lesion was located in the severely calcified and severely tortuous right iliac artery.A 6x150x130 innova self expanding stent was selected for the procedure.An ipsilateral approach was used to access the lesion.During the procedure, the guidewire crossed the occlusion in the right iliac artery and a balloon was used to pre-dilate.After the full stent was released from the system, the physician noticed that the stent moved position.The physician surgically cut the artery and removed half of the stent.The other half of the stent remained in the patient.There were no additional patient complications reported.The patient was stable post surgery.
 
Event Description
It was reported that the stent was not deployed in the targeted position.The severely stenosed target lesion was located in the severely calcified and severely tortuous right iliac artery.A 6x150x130 innova self expanding stent was selected for the procedure.An ipsilateral approach was used to access the lesion.During the procedure, the guidewire crossed the occlusion in the right iliac artery and a balloon was used to pre-dilate.After the full stent was released from the system, the physician noticed that the stent moved position.The physician surgically cut the artery and removed half of the stent.The other half of the stent remained in the patient.There were no additional patient complications reported.The patient was stable post surgery.It was further reported that the stent migrated in the vessel and the physician only removed part of the stent because the remaining portion was left to treat the vessel.
 
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 kinks to the outer sheath at the nosecone, 35cm and 40.5cm from the nosecone.The pull rack was separated 11.6cm from the knob.There was approximately 1.7cm of the pull rack sticking out of the handle.The separated ends of the rack do not match up.Microscopic examination revealed that the returned portion of the stent was in two pieces.The longer piece was approximately 3cm and the shorter piece was approximately 8mm long.The stent was cut horizontally.The proximal end of the tip was damaged.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that the stent was not deployed in the targeted position.The severely stenosed target lesion was located in the severely calcified and severely tortuous right iliac artery.A 6x150x130 innova self expanding stent was selected for the procedure.An ipsilateral approach was used to access the lesion.During the procedure, the guidewire crossed the occlusion in the right iliac artery and a balloon was used to pre-dilate.After the full stent was released from the system, the physician noticed that the stent moved position.The physician surgically cut the artery and removed half of the stent.The other half of the stent remained in the patient.There were no additional patient complications reported.The patient was stable post surgery.It was further reported that the stent migrated in the vessel and the physician only removed part of the stent because the remaining portion was left to treat the vessel.
 
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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 Key9375638
MDR Text Key168010762
Report Number2134265-2019-14433
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 12/19/2019
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 Date10/03/2021
Device Model Number26921
Device Catalogue Number26921
Device Lot Number0022746055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received11/26/2019
Supplement Dates Manufacturer Received12/15/2019
12/17/2019
Supplement Dates FDA Received12/17/2019
12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight55
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