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

Catalog Number EX062003L

Device Problems Break (1069); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

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 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 health care provider alleged a crack noise resulting in the stent not deploying further.The delivery system was able to be removed through the introducer sheath without issues from the patient.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 catheter sample it was confirmed that the stent could not be fully deployed.The stent housing including stent was found broken and was not returned for evaluation but deformation found on the proximal part of the delivery system indicated that the user could only partially deploy the stent by using the grip.Reportedly, the user felt a force increase when the failure occurred; it was therefore concluded that high friction affected the system during deployment leading to deployment failure and joint breakage.As a result of the investigation performed the complaint was confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.'.

Event Description

It was reported that during a vascular stent deployment procedure in the calcified femoral artery via a contralateral groin approach, the health care provider alleged a crack noise resulting in the stent not deploying further.The delivery system was able to be removed through the introducer sheath without issues from the patient.Reportedly, an alternative device was used to complete the procedure.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: 7283813
• MDR Text Key: 100661453
• Report Number: 9681442-2018-00018
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519003900
• UDI-Public: (01)04049519003900
• 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
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: EX062003L
• Device Lot Number: ANBP1207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 04/12/2018
• Supplement Dates FDA Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1