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

Catalog Number EX070803JL

Device Problems Fracture (1260); Premature Activation (1484); Failure to Advance (2524); Misfire (2532)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.The catalog number has not been cleared in the us, but is similar to the lifestent solo vascular stent system products that are cleared in the us.The 510 k number and pro code for the lifestent solo vascular stent system products are identified.(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 / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during a vascular stent deployment procedure, the delivery system became allegedly stuck at the beginning of the sfa as it was being advance to the lesion via a contralateral approach.It was further reported that during advancement alleged resistance was felt and a clicking sound was heard; therefore, the device was removed without incident from the patient.However, upon removal of the delivery system the health care provider (hcp) identified the vascular stent had allegedly partially deploy approximately 15mm.Reportedly, the hcp attempted to cover the stent in the guiding sheath unsuccessfully.So, the device and the guiding sheath were removed as one unit and after removal the hcp identified that the vascular stent had allegedly partially deployed further (approximately 65mm), and that part of the stent had allegedly fractured and was left in the sfa as it was secured against the vessel wall.The procedure was reportedly completed with another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of the returned sample it was confirmed that the deployment mechanism was not in use, that the stent prematurely deployed, and that the distal marker section of the stent fractured off.The proximal part of the stent was found inside the introducer sheath as reported.Based on the available information and the investigation of the returned sample the investigation was confirmed.A definite root cause could not be determined.Labeling review: in reviewing the applicable labeling it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'ensure that the stent is contained within the sheath.Do not use if the stent is partially deployed', and 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.'.

Event Description

It was reported that during a vascular stent deployment procedure, the delivery system became allegedly stuck at the beginning of the sfa as it was being advance to the lesion via a contralateral approach.It was further reported that during advancement alleged resistance was felt and a clicking sound was heard; therefore, the device was removed without incident from the patient.However, upon removal of the delivery system the health care provider (hcp) identified the vascular stent had allegedly partially deploy approximately 15mm.Reportedly, the hcp attempted to cover the stent in the guiding sheath unsuccessfully.So, the device and the guiding sheath were removed as one unit and after removal the hcp identified that the vascular stent had allegedly partially deployed further (approximately 65mm), and that part of the stent had allegedly fractured and was left in the sfa as it was secured against the vessel wall.The procedure was reportedly completed with another device.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
• MDR Report Key: 7301089
• MDR Text Key: 101115491
• Report Number: 9681442-2018-00022
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741110443
• UDI-Public: (01)00801741110443
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

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 Expiration Date: 07/31/2018
• Device Catalogue Number: EX070803JL
• Device Lot Number: ANAU2246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 93 YR