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

Catalog Number EX080803C

Device Problems Premature Activation (1484); Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2015

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 21 cfr 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 to provide further patient details.

Event Description

It was reported that during a stenting procedure for treatment of an iliac artery stenosis, the guide wire needed to be exchanged since it was not long enough.A partial stent deployment with the shipping lock in place was identified after the stent delivery system was being withdrawn from the patient.Another stent was used to complete the procedure successfully.There was no reported patient injury.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.The evaluation of the returned device confirmed the reported premature stent deployment.The stent was found to be partially released with the shipping lock in place and none of the tree different deployment methods being activated.Potential factors that could have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be associated with rough handling of the device during shipping, storage, preparation or use.The event also may have been caused by increased resistance between the guide wire and the guide wire lumen, or between the introducer sheath and the deployment system.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states: "visually inspect the distal end of the stent system to ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed." and "if resistance is met during stent system introduction, the stent system should be removed and another stent system should be used.".

• Brand Name: LIFESTENT 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: 5135120
• MDR Text Key: 28158412
• Report Number: 9681442-2015-00178
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: EX080803C
• Device Lot Number: ANZA0312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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: 55 YR