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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 SSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SSTEM Back to Search Results
Catalog Number 5F060801C
Device Problems Fracture (1260); Difficult to Remove (1528); Misfire (2532); Activation Failure (3270)
Patient Problem Injury (2348)
Event Date 05/17/2019
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.The catalog number identified has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent 5f vascular stent system products are identified expiry date (04/2020).(b)(4).
 
Event Description
It was reported that during creation of an av loop fistula in radial-cephalic in the left arm after alleged excessive force was felt, the delivery system allegedly failed to expand as the middle of the stent was attached to the inner catheter.Therefore, the health care provider (hcp) attempted to remove the delivery system toward the introducer sheath, resulting in an alleged stent fracture and stent bunching up into the anastomosis and into the cephalic outflow.Reportedly, the delivery system and the guidewire were removed as one unit, causing further bunching of the stent and a fractured segment to remain attached to the delivery system.It was further reported that a 7mm pta balloon was used to expand the bunched up stent, allowing fistula patency; however, additional intervention was needed (patient undergoing surgery) to correct the av loop fistula.
 
Event Description
It was reported that during creation of an av loop fistula in radial-cephalic in the left arm after alleged excessive force was felt, the delivery system allegedly failed to expand as the middle of the stent was attached to the inner catheter.Therefore, the health care provider (hcp) attempted to remove the delivery system toward the introducer sheath, resulting in an alleged stent fracture and stent bunching up into the anastomosis and into the cephalic outflow.Reportedly, the delivery system and the guidewire were removed as one unit, causing further bunching of the stent and a fractured segment to remain attached to the delivery system.It was further reported that a 7mm pta balloon was used to expand the bunched up stent, allowing fistula patency; however, additional intervention was needed (patient undergoing surgery) to correct the av loop fistula.
 
Manufacturer Narrative
H10: manufacturing review: no manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.A review of manufacturing records was performed, although no additional complaint has been reported for this lot.Investigation summary: based on the investigation of the returned catheter sample, and the images provided it was confirmed that the deployment system could only partially deploy the stent, and that stent fracture occurred upon removal.The deployment mechanism of the returned catheter sample was found actively used, the stent was found partially deployed, and the force transmitting distal outer sheath was found fractured in the loaded stent section which made a complete deployment impossible.Further use of the deployment mechanism led to further stent deployment proximal of the fractured position so that a segment of the stent was undeployed in the midst of the partially deployed stent.Upon removal the stent fractured in the anchored positions.An indication for a manufacturing related issue could not be found.Based on the investigation the reported issue was confirmed.A definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' regarding accessories the ifu state under 'materials required': '5f (1.67 mm) or larger introducer sheath (.) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire'.The ifu further state: 'the lifestent 5f vascular stent system is intended to improve lumina diameter in the treatment of symptomatic de novo or restenosis lesions in the native superficial femoral artery (sfa) and popliteal artery.' h10: expiry date (04/2020) h10: h6 (device code 2616 malposition of device) h10: g4 h11: h3, h6(device code, results, 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.
 
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Brand Name
LIFESTENT 5F VASCULAR STENT SSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key8693212
MDR Text Key147803505
Report Number9681442-2019-00074
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741119996
UDI-Public(01)00801741119996
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 07/30/2019
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 Catalogue Number5F060801C
Device Lot NumberANCR2660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2019
Initial Date Manufacturer Received 05/17/2019
Initial Date FDA Received06/12/2019
Supplement Dates Manufacturer Received07/25/2019
Supplement Dates FDA Received07/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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