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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT Back to Search Results
Catalog Number 5F051203CS
Device Problems Break (1069); Misfire (2532)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/14/2021
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2023).Device pending return.
 
Event Description
It was reported that during a stent placement procedure the tip of the stent allegedly broke.Reportedly, the health care provider allegedly was unable to snare the fragment.The current patient status is unknown.
 
Event Description
It was reported that during a stent placement procedure the tip of the stent allegedly broke.Reportedly, the health care provider allegedly was unable to snare the fragment.The current patient status is unknown.
 
Manufacturer Narrative
H10: this supplemental mdr is being submitted to report that mfr.Rpt # 9681442-2021-00441 was a duplicate record and was opened in error.The event details are being captured under complaint file # (b)(4) and was reported to the fda under mfr.Rpt # 9681442-2021-00439.H10: d4 (expiry date: 11/2023), g3.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
 
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Brand Name
LIFESTENT 5F VASCULAR STENT
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12329787
MDR Text Key266841834
Report Number9681442-2021-00441
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5F051203CS
Device Lot NumberANEY3110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
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
Patient Outcome(s) Required Intervention;
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