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

Catalog Number EX060803JL

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2017

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.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 further patient details to bard.Pma510(k): 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.

Event Description

It was reported that a stenting procedure for treatment of an in-stent restenosis of a competitor's stent (size 6 x 80) was performed.After the delivery system of the vascular stent (size 6 x 80 mm) was being advanced to the target site, the physician assessed that the vascular stent was shorter than the implanted competitor's stent.Therefore, stent deployment was discontinued and another stent of the same brand (size 6 x 100) 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 release for distribution.There is no indication for a manufacturing-related failure.During the evaluation of the returned stent delivery system of a 6 x 80 mm stent, the safety lock slider was found to be in locked position.The stent was found to be loaded in the systemin the correct position.The length of the stent was measured to be 80 mm which matches the specification of this device.Potential contributing factors to the reported event have been evaluated.As the reported issue was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.In this case, the reported deviation in the stent length with regard to the device labeling could not be confirmed during the evaluation of the returned sample.As no images were provided for evaluation, no further assessment could be performed.In general, comparisons with previously placed stents may lead to inaccurate results due to potential elongation of the previously placed stent.On the basis of the information available and the evaluation of the returned device, a definitive root cause for the reported event could not be determined.The ifu supplied with this device as well as the packaging label sufficiently reference the dimensions of the stent.Regarding stent size selection, the ifu states that the length of the target lesion should be measured to ensure complete covering of the lesion by the stent.The reported application of the treatment of an in-stent restenosis represents an off-label use of the device.According to the ifu, the device is intended for the treatment of symptomatic arterial de-novo or recurrent stenotic or occluded lesions in the native superficial femoral artery and proximal popliteal artery.Updated 'eval code & desc - conclusion 1' due to completion of evaluation.

Event Description

It was reported that a stenting procedure for treatment of an in-stent restenosis of a competitor's stent (size 6 x 80) was performed.After the delivery system of the vascular stent (size 6 x 80 mm) was being advanced to the target site, the physician assessed that the vascular stent was shorter than the implanted competitor's stent.Therefore, stent deployment was discontinued and another stent of the same brand (size 6 x 100) was used to complete the procedure successfully.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• 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: 6526044
• MDR Text Key: 74019913
• Report Number: 9681442-2017-00157
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: EX060803JL
• Device Lot Number: ANAP3432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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