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

Catalog Number EX060403C

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

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 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 was unable to provide any patient or procedural details to date.

Event Description

It was reported that the vascular stent could not be deployed at the lesion site.The stent delivery system was removed without issue and another stent was used to complete the procedure successfully.No patient injury 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 the reported failure to deploy the stent due to the breakage of a force transmitting component.Increased friction is considered the reason for increased release force and subsequent deployment failure.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.A difficult vessel anatomy or challenging placement site may result in high friction during the attempt to release the stent and subsequent deployment failure.The reported event also can be related to rough handling of the device during transport, unpacking or preparation.On the basis of the information available, a definite 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 stent system.Remove the stent system as possible, 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.".

Event Description

It was reported that the vascular stent could not be deployed at the lesion site in the sfa / proximal popliteal artery.The stent delivery system was removed without issue and another stent was used to complete the procedure successfully.No patient injury was reported.

• 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: 5234436
• MDR Text Key: 31586544
• Report Number: 9681442-2015-00221
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: EX060403C
• Device Lot Number: ANZF0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/20/2016; 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• 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: 73 YR
• Patient Weight: 55