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

Catalog Number EX080803C

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Misfire (2532); Material Deformation (2976)

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

Event Date 06/17/2022

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure through biliary tract of minor calcified tissue, the stent was allegedly failed to deploy.It was further reported that the plectrum was allegedly ruptured.The procedure was completed using another device.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 vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products 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 not been returned to the manufacturer for evaluation.However, a photo and images were provided for review.The investigation of the reported event is currently underway.(expiry date: 10/2023).

Event Description

It was reported that during a stent placement procedure through biliary tract of minor calcified tissue, the stent was allegedly failed to deploy.It was further reported that the plectrum was allegedly ruptured.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: 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.Investigation summary: the catheter sample is not available for evaluation.Provided images demonstrate the dis assembled system after the event on the table.A break of the rapid deployment ring could not be identified but the primary sheath is broken which was considered the reason for the partial deployment.One image demonstrates the released stent inside patient which confirms stent deformation.Even though a snapshot demonstrating the moment of a partially deployed stent would not be enough to verify partial deployment, incomplete respectively partial stent deployment is considered confirmed, based on detailed information provided.A manufacturing related issue could not be found.Based on the investigation of the provided information, the investigation is confirmed for break of the stent sheath leading to partial deployment and subsequent stent deformation.A definite root cause for the reported event could not be determined.The reported indication represents an off label use.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Holding and handling of the system throughout deployment was found sufficiently described, in particular the instruction for use state: 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.', and 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.', and 'predilitation of the lesion should be performed using standard techniques.' the instruction for use further 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 regard to damage the instruction 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.' the lifestent vascular stent is intended for primary stenting of de-novo or restenotic lesions of the peripheral arteries.H10: d4 (expiry date: 10/2023), 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 : device not returned.

• 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: 15011542
• MDR Text Key: 302433451
• Report Number: 9681442-2022-00209
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001784
• UDI-Public: (01)04049519001784
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 07/20/2022

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: EX080803C
• Device Lot Number: ANFX0238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 07/30/2022
• Supplement Dates FDA Received: 08/04/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female