Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM; VASCULAR STENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT STENT SYSTEM; VASCULAR STENT Back to Search Results
Catalog Number EX061203C
Device Problems Fracture (1260); Obstruction of Flow (2423)
Patient Problems Injury (2348); Obstruction/Occlusion (2422)
Event Date 11/05/2019
Event Type  Injury  
Manufacturer Narrative
An images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.(expiry date: 09/2020).
 
Event Description
It was reported that approximately three weeks post placement in the right superficial femoral artery via right femoral artery approach treating an 80% stenosis, the stent was allegedly identified to be fractured.It was further reported that an additional surgical procedure was required to implant additional stent grafts and improve blood flow.The patient is reportedly stable.
 
Event Description
It was reported that approximately three weeks post placement in the right superficial femoral artery via right femoral artery approach treating an 80% stenosis, the stent was allegedly identified to be fractured.It was further reported that an additional surgical procedure was required to implant additional stent grafts and improve blood flow.The patient is reportedly stable.
 
Manufacturer Narrative
H10: this supplemental mdr is being submitted to report file # (b)(4) was duplicated in error submitted on fda report number 9681442-2020-00072.File # (b)(4) is the original record and will have all the recorded information which was submitted on fda report number 9681442-2019-00248.H10: d4(expiry date: 09/2020), g4.H11: h6 (results and conclusion).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LIFESTENT STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9913829
MDR Text Key187057790
Report Number9681442-2020-00072
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519001463
UDI-Public(01)04049519001463
Combination Product (y/n)N
PMA/PMN Number
P070014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEX061203C
Device Lot NumberANCW2260
Was Device Available for Evaluation? No
Date Manufacturer Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight76
-
-