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

Catalog Number EX061003JL

Device Problems Kinked (1339); Difficult to Remove (1528); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient details.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 # (b)(4).

Event Description

It was reported that after successful deployment of the vascular stent in a pre-dilated, calcified lesion in the sfa of 15 cm length via access through the left brachial artery, the stent delivery system could not be withdrawn over the 0.014" guide wire and got stuck.The delivery system and guide wire were removed as a single unit and the procedure was completed successfully.The guide wire and the delivery system were separated outside the patient.There was 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, the reported difficulties in removing the guide wire post stent deployment could be confirmed.The subject guide wire was not returned as it could be separated from the system outside patient.The returned delivery system was found to be damaged and kinked close to the grip which led to a loss of integrity of the guide wire lumen and the guide wire patency problems.It is unknown at which point in time this damage occurred.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be related to a difficult vessel anatomy leading to increased friction.In this case, access was gained through the brachial artery and the lesion had been pre-dilated.Insufficient flushing of the device may be another contributing factor to the reported event.The use of a 0.014" guide wire also may have contributed to the reported event.The reported event also may be use-related as rough handling of the device can lead to kinking/damage and subsequent friction increase.On the basis of the information available and the evaluation of the returned device, 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 "flush the inner lumen of the stent system with heparinized normal saline prior to use." the ifu also states: "keep the device as straight as possible following removal from the packaging and while inserted in the patient.Failure to do so may impede the optimal deployment of the implant." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together." furthermore, the ifu indicates that a 0.035" guide wire is required for the procedure.

Event Description

It was reported that after successful deployment of the vascular stent in a pre-dilated, calcified lesion in the sfa of 15 cm length via access through the left brachial artery, the stent delivery system could not be withdrawn over the 0.014" guide wire and got stuck.The delivery system and guide wire were removed as a single unit and the procedure was completed successfully.The guide wire and the delivery system were separated outside the patient.There was 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: 6150915
• MDR Text Key: 61617262
• Report Number: 9681442-2016-00318
• 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: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: EX061003JL
• Device Lot Number: ANZL2208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1