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

Model Number EX062003CL

Device Problems Break (1069); Fracture (1260); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.As the lot number for the device was not provided, a review of the device history records has not been performed.The return of the device is pending.The investigation is currently underway.(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 in a severe stenosis, left sfa via a right femoral approach, the vascular stent delivery system allegedly broke and the stent allegedly partially deployed.Therefore, the health care provider decided to remove the delivery system, however, upon removal the stent allegedly fractured and a segment detached and remained in the patient.Reportedly, another stent was deployed to secure the segment against the vessel wall.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 a partial stent deployment and stent fracture was confirmed.A force transmitting component of the delivery system was found broken which made a complete stent deployment impossible.Subsequent stent fracture occurred during removal of the partially released and flowered stent.Therefore, based on the available information and the evaluation of the returned sample the investigation was confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' in regards to guidewire the ifu states: 'insert a 0.035¿ guidewire of appropriate length (see table) and diameter across the lesion to be stented via the introducer sheath.', and 'advance the stent system over the 0.035¿ guidewire through the sheath introducer.'.

Event Description

It was reported that during a vascular stent deployment procedure in a severe stenosis, left sfa puncture via a right femoral approach, the vascular stent delivery system allegedly broke and the stent allegedly partially deployed.Therefore, the health care provider decided to remove the delivery system, however, upon removal the stent allegedly fractured and a segment detached and remained in the patient.Reportedly, another stent was used to treat the lesion, and a further stent was deployed to secure the segment against the vessel wall.Manual pressure was held for hemostasis.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7513111
• MDR Text Key: 108233930
• Report Number: 9681442-2018-00060
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANCP0642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1