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

Catalog Number EX080401C

Device Problems Loss of or Failure to Bond (1068); Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, the device sheath allegedly detached from the system.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent stent system products that are cleared in the us.The pro code and 510 k number for the lifestent stent system products are identified.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.(expiration date: 06/2023).

Event Description

It was reported that during a stent placement procedure in the iliac artery for stenosis treatment with ipsilateral femoral access, the device sheath allegedly broke and detached from the system after stent deployment.Reportedly the sheath could be removed.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 stent system products that are cleared in the us.The pro code and 510 k number for the lifestent stent system products 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 returned catheter sample was found with deployed stent, and with separated inner catheter because the adhesive joint between luer and metal hypotube was found loose.Based on the information available the investigation is confirmed for loose adhesive joint inside grip leading to inner catheter detachment.The lesion was not pre dilated but the stent could be released without difficulty.System compatible introducer and guidewire were being used for access.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: 'if resistance is met while retracting the stent system over a guidewire, remove the stent system and guidewire together.' in addition, the instructions for use state: 'predilitation of the lesion should be performed using standard techniques.' in regards to accessories the instructions for use state: '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'.In regards to damage the instructions for use state: 'examine the stent and delivery system device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.' h10: b5, d4 (expiry date: 06/2023), g3.H11: h6 (device, method, 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.

• Brand Name: LIFESTENT STENT SYSTEM
• 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: 13235344
• MDR Text Key: 285674173
• Report Number: 9681442-2021-00661
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001739
• UDI-Public: (01)04049519001739
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX080401C
• Device Lot Number: ANFT3442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• 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