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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO STENT; VASCULAR STENT
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO STENT; VASCULAR STENT Back to Search Results
Catalog Number EX062003JL
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the lifestent solo vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 10/2022).
 
Event Description
It was reported that post stent placement procedure to the lesion in the superficial femoral artery via a contralateral approach, the device was allegedly difficult to be removed.Reportedly, the device possibly got caught with a stent which had already been placed in external iliac artery.The was no reported patient injury.
 
Event Description
It was reported that post stent placement procedure to the lesion in the superficial femoral artery via a contralateral approach, the device was allegedly difficult to be removed.Reportedly, the device possibly got caught with a stent which had already been placed in external iliac artery.There was no reported patient injury.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the returned delivery system was evaluated and was found without damage/ deformation indicating a removal difficulty or entrapment with another stent.Images/ dicoms demonstrating the removal process were not provided so that the system getting caught on another stent could not be confirmed.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'gain femoral access utilizing a 6 fr (2 mm) or larger introducer sheath.Always use for contralateral access the stent system in conjunction with a long introducer sheath (¿)' and 'always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site.6 fr (2 mm) or larger introducer sheath should be used.', and 'during stent deployment, use the 0.035" guidewire (recommended) for more support depending on vascular anatomy and / or lesion morphology.' the instructions for use further state: '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.' in regards to pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques.' h10: d4 (expiry date: 10/2022), g3 h11: h6 (result, 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.H3 other text : see h10.
 
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Brand Name
LIFESTENT SOLO STENT
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key12292187
MDR Text Key265583190
Report Number9681442-2021-00426
Device Sequence Number1
Product Code NIP
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 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEX062003JL
Device Lot NumberANEX1636
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Date Manufacturer Received10/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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