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

Catalog Number EX061503C

Device Problems Fracture (1260); Obstruction of Flow (2423)

Patient Problems Occlusion (1984); No Consequences Or Impact To Patient (2199)

Event Date 11/02/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the lot 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.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: three images were provided for evaluation.Based on the provided images the reported stent fracture could be confirmed.A blood flow inside the stent could not be identified which indicated that the vessel was occluded which could have led to the reported stent fracture.A manufacturing related issue could not be identified.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu closely describes the stent placement by stating: 'confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.(.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position.(.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum.(.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.' the ifu also mentions balloon pre and post dilation: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.' (expiry date 01/2020).

Event Description

It was reported that approximately nine months post stent placement procedure in a ninety to one-hundred percent vascularly closed sfa, the stent was allegedly found to be fractured.It was further reported that a second device was used to cover the fractured stent.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot 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.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported investigation summary: three images were provided for evaluation.Based on the provided images the reported stent fracture could be confirmed.A blood flow inside the stent could not be identified which indicated that the vessel was occluded which could have led to the reported stent fracture.A manufacturing related issue could not be identified.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu closely describes the stent placement by stating: 'confirm that the introducer sheath is secure and will not move during deployment (.) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment (.) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.(.) initiate stent deployment by rotating the thumbwheel in the direction of the arrows while holding the handle in a fixed position.(.) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1cm minimum.(.) with distal end of the stent apposing the vessel wall, deployment continues with the following method (.) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.' the ifu also mentions balloon pre and post dilation: 'predilation of the lesion should be performed using standard techniques.' and 'post stent expansion with a pta catheter is recommended.'.

Event Description

It was reported that approximately nine months post stent placement procedure in a ninety to one-hundred percent vascularly closed sfa, the stent was allegedly found to be fractured.It was further reported that a second device was used to cover the fractured stent.There was no reported patient injury.

• Brand Name: LIFESTENT 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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8126007
• MDR Text Key: 129094117
• Report Number: 9681442-2018-00209
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001487
• UDI-Public: (01)04049519001487
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061503C
• Device Lot Number: ANCN1509
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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): Other