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

Model Number EX071503CS

Device Problems Entrapment of Device (1212); Fracture (1260); Misfire (2532)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.(expiry date: 09/2021).

Event Description

It was reported that during a stent placement procedure, the stent allegedly partially deployed.It was further reported that stent get caught and fractured while removing.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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.Investigation summary: the sample was not returned for evaluation.Therefore, the investigation is inconclusive for the reported issues.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit.' holding and handling of the system throughout deployment was found sufficiently described; in particular the instruction for use state: '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.' under materials required the instruction for use state: 6f (2.0 mm) or larger introducer sheath, 0.035¿ diameter guidewire in addition the packaging pictograms indicate the use of a 6f introducer and a 0.035" guidewire.In regards to pre pta the instructions for use state: 'predilation of the lesion should be performed using standard techniques.' h10: d4 (expiry date: 09/2021).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.H3 other text : device not returned.

Event Description

It was reported that during a stent placement procedure, the stent allegedly partially deployed.It was further reported that stent get caught and fractured while removing.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12426169
• MDR Text Key: 270537485
• Report Number: 9681442-2021-00485
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001326
• UDI-Public: (01)04049519001326
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EX071503CS
• Device Catalogue Number: EX071503CS
• Device Lot Number: ANDW4318
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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