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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number H74939293072030
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/30/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at time of event: elderly.(b)(4).It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
 
Event or Problem Description
It was reported that a stent fracture occurred.A 7x200x130 innova¿ stent was successfully implanted in the common femoral-iliac artery.The stent delivery system was removed and the stent was post dilated.The physician then noted that the stent appeared fractured.No additional intervention was performed.No patient complications were reported and the patient is fine and recovering.
 
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Brand Name
INNOVA¿
Common Device Name
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
MDR Report Key6887240
Report Number2134265-2017-09386
Device Sequence Number19009171
Product Code NIP
UDI-Device Identifier08714729874157
UDI-Public08714729874157
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P140028
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/30/2017
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
Operator of Device Health Professional
Device Expiration Date09/30/2019
Device Model NumberH74939293072030
Device Catalogue Number39293-07203
Device Lot Number19693528
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2017
Initial Report FDA Received Date09/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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