MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT SOLO VASCULAR STENT SYSTEM

Catalog Number EX062001JL

Device Problems Premature Activation (1484); Use of Device Problem (1670); Failure to Advance (2524); Compatibility Problem (2960)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under # p070014.

Event Description

It was reported that during a stenting procedure for treatment of a lesion in the sfa via ipsilateral approach, the stent delivery system could not be inserted into a not commercially available 6 f introducer sheath through a self made sidehole over a 0.035" guide wire.Reportedly, the vascular stent became prematurely released and the distal part of the outer sheath allegedly turned outward.Two other delivery systems also could not be inserted through the sidehole.Another device was used to complete the procedure.There was no patient involvement and no reported patient injury.

Manufacturer Narrative

The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned device and the introducer sheath, the reported premature stent deployment could not be confirmed.The tip was found to be undamaged and the stent was found to be fully released upon sample receipt.No damage of the distal catheter end indicating any insertion difficulty was identified.The reported event could not be reproduced.Potential contributing factors to the reported event have been evaluated.The reported event was found to be an isolated incident.Therefore, no previously reported similar complaints could have been reviewed.The reported event may be use-related as the user tried to insert the delivery system through a sidehole into a non-commercially available introducer sheath.During evaluation of the returned introducer sheath it was found that the edges of the sidehole may carry the risk of an insertion failure.The reported event also may be related to improper shipping, storage or unpacking of the device as a damaged tip section may lead to insertion difficulties.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.The ifu states: "gain femoral access utilizing a 6 f (2 mm) or larger introducer sheath." and "if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used." updated 'patient code + description' due to additional information received.Updated 'device code + description2' due to additional information received.Updated 'eval code & desc - conclusion1' due to completion of evaluation.

Event Description

It was reported that during a stenting procedure for treatment of a lesion in the sfa via ipsilateral approach, the stent delivery system could not be inserted into a non-commercially available 6 f introducer sheath through a selfmade sidehole over a 0.035" guide wire.Reportedly, the vascular stent became prematurely released and the distal part of the outer sheath allegedly turned outward.Two other delivery systems also could not be inserted through the sidehole.Another device was used to complete the procedure.There was no patient involvement and no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6296863
• MDR Text Key: 66447653
• Report Number: 9681442-2017-00043
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: EX062001JL
• Device Lot Number: ANAV3727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 70