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

Catalog Number EX061003C

Device Problems Fracture (1260); Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problems Injury (2348); Obstruction/Occlusion (2422)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Four images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.Expiry date: 03/2021).

Event Description

It was reported that approximately three weeks post placement in the right superficial femoral artery via right femoral artery approach treating an 80% stenosis, the stent was allegedly identified to be fractured.It was further reported that an additional surgical procedure was required to implant additional stent grafts and improve blood flow.The patient is reportedly stable.

Event Description

It was reported that approximately three weeks post placement in the right superficial femoral artery via right femoral artery approach treating an 80% stenosis, the stent was allegedly identified to be fractured.It was further reported that an additional surgical procedure was required to implant additional stent grafts and improve blood flow.The patient is reportedly stable.

Manufacturer Narrative

H10: manufacturing review: the lot history records of this lot were 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Based on x-ray images provided a stent twisting was confirmed.The single stent struts were not visible but the appearance of the stent like an hour glass confirmed that the stent was twisted.The images also demonstrated total occlusion.An indication for a process related issue could not be identified.The twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product it was found that the ifu sufficiently described the correct deployment of the stent.The ifu state: '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: 'post stent expansion with a pta catheter is recommended.' and 'predilation of the lesion should be performed using standard techniques'.H10: d4(expiry date: 03/2021).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that approximately three weeks post placement in the right superficial femoral artery via right femoral artery approach treating an 80% stenosis, the stent was allegedly identified to be fractured.It was further reported that an additional surgical procedure was required to implant additional stent grafts and improve blood flow.The patient is reportedly stable.

Manufacturer Narrative

H10: this supplemental mdr is being submitted to report file # 1588205 was duplicated in error submitted on fda report number 9681442-2020-00073.File # 1528098 is the original record and will have all the recorded information which was submitted on fda report number 9681442-2019-00250.Manufacturing review: the lot history records of this lot were 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Based on x-ray images provided a stent twisting was confirmed.The single stent struts were not visible but the appearance of the stent like an hour glass confirmed that the stent was twisted.The images also demonstrated total occlusion.An indication for a process related issue could not be identified.The twisting of this kind of stent is caused by interactions of various use related and anatomical factors with the given stent design.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product it was found that the ifu sufficiently described the correct deployment of the stent.The ifu state: '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: 'post stent expansion with a pta catheter is recommended.' and 'predilation of the lesion should be performed using standard techniques'.H10: d4(expiry date: 03/2021),.

• Brand Name: LIFESTENT STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9913784
• MDR Text Key: 187058378
• Report Number: 9681442-2020-00073
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001449
• UDI-Public: (01)04049519001449
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061003C
• Device Lot Number: ANDQ2735
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 06/17/2020
• Supplement Dates FDA Received: 05/18/2020; 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 76