MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT

Catalog Number ZVL07040

Device Problems Premature Activation (1484); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Premature Separation (4045)

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

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2023).

Event Description

It was reported that during stent deployment procedure, the stent allegedly had difficulty while loading on guide wire and the sheath allegedly hooked to sent after deployment, it was further reported that the guide wire allegedly had difficulty to remove after stent deployment.There was no reported patient injury.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted to fda, therefore, the file will remain assessed as a malfunction.H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2023).H11: section a through f: the information provide by bd represents all 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 during stent deployment procedure, the stent allegedly had difficulty while loading on guide wire and the sheath allegedly hooked to stent after deployment.It was further reported that the guide wire allegedly had difficulty to remove after stent deployment.There was no reported patient injury.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11385065
• MDR Text Key: 250451958
• Report Number: 9681442-2021-00067
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P080007
• 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: 03/02/2021

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 Catalogue Number: ZVL07040
• Device Lot Number: ANEU3241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other