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

Catalog Number EX061703C

Device Problems Difficult or Delayed Positioning (1157); Sticking (1597); Physical Resistance (2578)

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

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.(b)(6).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).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 it was difficult to deploy a stent.The delivery system crossed the lesion with moderate resistance.When the physician removed the safety clip and started to rotate the wheel slowly, he found it was difficult to rotate it.The physician used the fast track deployment lever instead; strong resistance was felt as well.However, the physician was able to deploy the stent and complete the procedure.

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 the specification prior to shipment.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case the stent was implanted into the patient and the delivery system was not provided for evaluation.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore previous investigations of similar complaints have been reviewed.The event may have been associated with difficult anatomic conditions.Insufficient flushing of the device or not performed predilation could be another contributing factor.Reportedly, the delivery system was flushed prior to use.It was reported that the lesion was not pre-dilated.Based on the information available and because no sample was returned for evaluation, a definite root cause could not be determined.In reviewing the labeling supplied with this product and 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 stent system.Remove the stent system as possible and replace with a new unit." the ifu states: "flush the inner lumen of the device with saline prior to use." and "predilation of the lesion should be performed using standard".

• 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: frank kirchner ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5356303
• MDR Text Key: 35802261
• Report Number: 9681442-2016-00011
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• 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: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: EX061703C
• Device Lot Number: ANYF3585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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 Age: 60 YR
• Patient Weight: 65