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

Catalog Number EX061203C

Device Problems Failure to Advance (2524); Misfire (2532); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number of 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 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 during a stent procedure for treatment of atherosclerosis in the left lower limb antegrade right femoral approach, the stent allegedly could not cross the lesion.It was further reported that the procedure was completed with another device.There was no reported patient injury.

Event Description

It was reported that during a stent procedure for treatment of atherosclerosis in the left lower limb with antegrade right femoral approach, the stent allegedly could not cross the lesion.It was further reported that the procedure was completed with another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number has not been cleared in the us, but is similar to the lifestent stent system products that are cleared in the us.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.Investigation summary: based on the investigation of the returned catheter sample the alleged inability to cross the lesion could not be confirmed.The stent was found partially released but the shipping lock was found removed and the thumbslider was found in used condition.Besides the partial deployment the system, especially the tip, was found in good condition.Residuals of blood could not be found.The investigation will be closed with inconclusive result because the event could not be re produced.An indication for a process related issue could not be found.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.' and 'examine the stent and delivery system device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.' in regards to the shipping lock the ifu states: 'extract the stent and delivery system from the tray and check the following: verify that the shipping lock is still secure in the delivery system handle.', and 'prior to deployment the shipping lock must be removed and discarded.'.

• 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 Key: 7445480
• MDR Text Key: 106042537
• Report Number: 9681442-2018-00048
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001463
• UDI-Public: (01)04049519001463
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• 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 Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: EX061203C
• Device Lot Number: ANAZ3515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR