MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number 5F061503C

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified.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 for evaluation.The investigation of the reported event is currently underway.Expiry date: 03/2021.

Event Description

It was reported that during device removal procedure post stent placement to the lesion in the superficial femoral artery via contralateral approach, the device was allegedly difficult to remove since it got caught with a stent which had already been placed in external iliac artery.Further more, upon being pulled forcefully to remove the device, the inner shaft allegedly broke off.Reportedly, the broken fragment was recovered using a snare.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.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 returned for evaluation.The user reportedly felt resistance during removal cause by a previously placed stent.The returned sample was found with released stent and with broken cardan tube which confirms the alleged inner catheter break after successful deployment.Detachment of the broken segment was considered a subsequent event.Images/ dicoms demonstrating the removal difficulty were not provided so that entrapment with a previously placed stent is inconclusive.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 instructions for use state: '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.' in regards to pre dilation the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use state: '5f (1.67 mm) or larger introducer sheath (¿) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire'.The instructions for use further state: 'recrossing a partially or fully deployed stent with adjunct devices must be performed with caution.', and 'always use an introducer sheath for the implant procedure to protect the vasculature and the puncture site.' h10: the original lot no andq0643 expiry date is 01-mar-2021 so the lot is reworked for extended expiry date.The reworked lot no is andq0643r expiry date is 01-mar-2022 but in tw system not finding the lot no with r so the lot no updated as andq0643.H10: g3, h6 (device) h11: h6 (result, conclusion) 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 : see h10.

Event Description

It was reported that during device removal procedure post stent placement to the lesion in the superficial femoral artery via contralateral approach, the device was allegedly difficult to remove since it got caught with a stent which had already been placed in external iliac artery.Further more, upon being pulled forcefully to remove the device, the inner shaft allegedly broke off.Reportedly, the broken fragment was recovered using a snare.There was no reported patient injury.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 12292185
• MDR Text Key: 265581871
• Report Number: 9681442-2021-00427
• Device Sequence Number: 1
• Product Code: NIP
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F061503C
• Device Lot Number: ANDQ0643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other