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

Catalog Number EX070603C

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Misfire (2532)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

It was reported that during a stent graft placement procedure, when trying to deploy the stent, the doctor noticed that the release system wheel allegedly felt loose and was turning but without releasing the device.It was further reported that the handle allegedly had some fractures.The procedure was completed using another device.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 vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2023).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 pending return.

Event Description

It was reported that during a stent graft placement procedure, the doctor noticed that the release system wheel allegedly feels loose and turning but without releasing the device when trying to deploy the stent.It was further reported that the handle was allegedly had some fractures.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was not returned for evaluation.No images were provided for review.Based on the information available and as no sample was returned for evaluation, the investigation is closed with inconclusive result.A definite root cause for the reported issue could not be determined.Labeling review: relevant labeling for this product was reviewed.The instructions for use was found to address the potential risk: "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." regarding preparation the instructions for use states: "pre-dilatation of the lesion should be performed using standard techniques." and "gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire".Correct handling of the device during deployment was found sufficiently described: "do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment." h10: d4 (expiry date: 11/2023), g3 h11: h6 (device, result, conclusion) h11: section a through f ¿ the information provided 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.H3 other text : device not returned.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was not returned for evaluation.A photo was provided, showing the handle of the delivery system in the area of the deployment wheel.Even though minor gaps between the grip shells of the handle can be identified, no product defects related to the alleged impossibility to deploy the stent could be identified.The stent was intended to be placed in the superficial femoral artery with contralateral access, the lesion was predilated, and device compatible accessories were used.Based on the information available and as the delivery system was not returned for evaluation, the investigation is closed with inconclusive result.A definite root cause for the reported issue could not be determined.Labeling review: relevant labeling for this product was reviewed.The instructions for use was found to address the potential risk: "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." regarding preparation the instructions for use states: "pre-dilatation of the lesion should be performed using standard techniques." and "gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire".Correct handling of the device during deployment was found sufficiently described: "do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.".H10: b5, d4 (expiry date: 11/2023), g3, h6 (method).H11: section a through f ¿ the information provided 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.H3 other text : device not returned.

Event Description

It was reported that during a stent graft placement procedure in the superficial femoral artery via the femoral contralateral approach, the doctor noticed that the release system wheel allegedly felt loose and turning but without releasing the device when trying to deploy the stent.It was further reported that the handle allegedly had some fractures.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a stent graft placement procedure in the superficial femoral artery via the femoral contralateral approach, the doctor noticed that the release system wheel allegedly felt loose and turning but without releasing the device when trying to deploy the stent.It was further reported that the handle allegedly had some fractures.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: manufacturing review: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the delivery system was returned for evaluation, with the stent being partially deployed.A force transmitting component - the cassette post - inside the handgrip was found to be broken; therefore, complete stent deployment using the deployment wheel was impossible.A photo has been provided previously, showing the handle of the delivery system in the area of the deployment wheel.Even though minor gaps between the grip shells of the handle can be identified, no product defects related to the alleged impossibility to deploy the stent could be identified.The stent was intended to be placed in the superficial femoral artery with contralateral access, the lesion was predilated, and device compatible accessories were used.Based on evaluation of the sample breakage of a force transmitting component is confirmed, which led to incomplete deployment of the stent.The break is considered a consequence of increased deployment forces.However, a definite root cause for the reported issue could not be determined.Labeling review: relevant labeling for this product was reviewed.The instructions for use was found to address the potential risk: "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".Regarding preparation the instructions for use states: "predilatation of the lesion should be performed using standard techniques" and "gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire".Correct handling of the device during deployment was found sufficiently described: "do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment".H10: d4 (expiration date: 11/2023), g3, h2, h6 (device) h11: h6 (method, result) h11: section a through f ¿ the information provided 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.H3 other text : see h10.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17787278
• MDR Text Key: 323895386
• Report Number: 9681442-2023-00327
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX070603C
• Device Lot Number: ANFY2936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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