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

Catalog Number EX061703C

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Sticking (1597)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/03/2015

Event Type  Injury  

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.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 patient details.

Event Description

It was reported that during the stent placement procedure, the deployment mechanism of the delivery system got stuck and the vascular stent could not be deployed.It was not possible to resheath or continue to deploy.The whole delivery system was broken in order to get access to the catheter the sheath was mounted on.During removal of the delivery system, the stent finally fractured inside the patient.The placement of additional stents was necessary to cover the area.No injury to the patient was reported.

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.The evaluation of the returned device confirmed that the stent was being partially deployed and fractured during the attempt to remove the system from the patient.The condition of the device indicates the presence of high release force.The proximal stent end was found inside the introducer sheath leading to the conclusion that the distal stent end remained in the patient.It is also confirmed that the guide wire got stuck inside the system and that the system was disassembled for removal.Potential contributing factors to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.A difficult vessel anatomy, a challenging placement site or the use of inappropriate accessories may have contributed to the deployment failure.Reportedly, a smaller guide wire than recommended in the ifu was used during the procedure.The stent fracture was determined to be a consequence of the attempt to remove the partially deployed stent from the patient.The guide wire that was found stuck inside the inner lumen is considered a consequence of excessive release force and luminal deformation.On the basis of the information available, a definitive root cause for the reported event could not be determined.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." 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." the ifu recommends the use of a 0.035 inch guide wire.

Event Description

It was reported that the vascular stent could not be deployed in the superior femoral artery.As reported the device has been flushed prior to use.A 0.018 inch guide wire was used.The lesion was pre-dilated.Reportedly during the stent placement procedure, the deployment mechanism of the delivery system got stuck and it was not possible to re-sheath or continue to deploy.The whole delivery system was broken in order to get access to the catheter the sheath was mounted on.During removal of the delivery system, the stent finally fractured inside the patient.The placement of additional stents was necessary to cover the area.No injury to the patient was reported.

• Brand Name: LIFESTENT XL VASCULAR STENT
• 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: 5257947
• MDR Text Key: 32405687
• Report Number: 9681442-2015-00232
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: EX061703C
• Device Lot Number: ANYK0802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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
• Patient Outcome(s): Required Intervention