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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA SELF-EXPANDING STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC - MAPLE GROVE INNOVA SELF-EXPANDING STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number UNK695
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
It was reported that the stent shortened.An innova self-expanding stent was selected for a procedure in the leg and during an unknown time in the procedure it was reported that the stent shortened.No patient complications were reported.
 
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Brand Name
INNOVA SELF-EXPANDING STENT SYSTEM
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7071477
MDR Text Key93457628
Report Number2134265-2017-11402
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/02/2017
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 Model NumberUNK695
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2017
Initial Date FDA Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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