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

Catalog Number EX060601C

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 09/10/2015

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 # (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 details.

Event Description

It was reported that after placement of the vascular stent in the right external iliac artery, the delivery system became blocked on the guide wire during removal and the inner sheath of the delivery system fractured.Allegedly, the distal tip of the delivery system detached.On the images taken post removal of the introducer sheath, a migration of the vascular stent was discovered.An arteriotomy was performed to remove the stent.Another stent was placed to 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 all specifications prior to release for distribution.There is no indication for a manufacturing-related failure.During the evaluation of the returned device, the distal segment of the inner catheter including the atraumatic tip was found to be broken.In addition, a fractured stent segment with a length of 20 mm was returned for evaluation.The disposition of the remaining stent segment with a length of 40 mm is unknown.Potential factors which may have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.In this case, it was reported that the delivery system got stuck on the guide wire post stent deployment followed by a rupture of the inner catheter.On the basis of the sample evaluation, a breakage of the inner catheter and a fracture of the stent can be confirmed.The reported event may be related to the tip of the inner catheter becoming caught on the implanted stent.This kind of event may be associated with an irregular stent placement leading to stent struts extending into the stent lumen upon deployment and a subsequently increased risk of entrapment.A difficult vessel anatomy, a challenging placement site, an inadvertent movement of the hand or incorrect holding of the delivery system during stent deployment may lead or contribute to an irregular stent placement.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu supplied with this device addresses the potential factor of an irregular stent placement and sufficiently describes the correct application of the device.Also the ifu states: "deployment of the stent is complete when the proximal stent radiopaque markers appose the vessel wall and the sheath radiopaque zone is proximal to the proximal stent radiopaque markers." also the ifu indicates that malpositioning of the stent is a potential adverse event that may occur.Furthermore, the ifu states: "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.".

• 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: 5153338
• MDR Text Key: 28413630
• Report Number: 9681442-2015-00190
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: EX060601C
• Device Lot Number: ANYE2223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2014
• 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
• Patient Age: 69 YR
• Patient Weight: 85