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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT VASCULAR STENT SYSTEM Back to Search Results
Catalog Number EX070601C
Device Problems Positioning Failure (1158); Difficult to Remove (1528); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.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 vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent vascular stent system products are identified.The information provided by bard 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 bard.
 
Event Description
It was reported that the stent allegedly partially deployed during an attempt to treat the right external iliac via a contralateral approach.Therefore, the device was removed from the patient without incident.However, the health care provider (hcp) was only able to perform angioplasty as the hcp did not have another stent handy to complete the procedure.There was no reported patient injury.
 
Event Description
It was reported that the stent allegedly partially deployed during an attempt to treat the right external iliac via a contralateral approach.Therefore, the device was removed from the patient without incident.However, the health care provider (hcp) was only able to perform angioplasty as the hcp did not have another stent handy to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned sample it was confirmed that the stent was partially released and that the user could withdraw the partially released stent system including introducer from the patient without stent fracture.The deployment mechanism was found activated a few [mm] and the stent was found nearly fully released inside the introducer which led to the conclusion that removal activity of the failed system led to further deployment inside the introducer sheath.The grip including mechanics was found fully functioning; it was therefore concluded that increased friction during deployment and subsequent release force increase led to the reported event.As a result of the investigation performed the complaint was confirmed.However, based on the available information, and the sample evaluation a definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit'.In this case the user followed the ifu and removed the system.The catalog number has not been cleared in the us, but is similar to the lifestent vascular stent system products that are cleared in the us.
 
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Brand Name
LIFESTENT VASCULAR STENT SYSTEM
Type of Device
VASCULAR STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key7474427
MDR Text Key107074148
Report Number9681442-2018-00051
Device Sequence Number1
Product Code NIP
UDI-Device Identifier04049519001579
UDI-Public(01)04049519001579
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 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2020
Device Catalogue NumberEX070601C
Device Lot NumberANCP2138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2018
Date Manufacturer Received06/07/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age89 YR
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