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

Catalog Number VIEL08100

Device Problems Break (1069); Fracture (1260); Material Separation (1562); Misfire (2532); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular stent 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.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 04/2025).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.

Event Description

It was reported that during a stent placement procedure in iliac artery, the part from the blue t-type luer fitting to the tail end was unable to be retracted and released continuously since great resistance was encountered.It was further reported that the outer sheath for stent delivery system was allegedly ruptured.Reportedly, the tip of the stent was wrapped and remained in the body of this patient.The current status of the patient is unknown.

Event Description

It was reported that during a stent placement procedure in iliac artery, the part from the blue t-type luer fitting to the tail end was unable to be retracted and released continuously since great resistance was encountered.It was further reported that the outer sheath for stent delivery system was allegedly ruptured.Reportedly, the tip of the stent was wrapped and remained in the body of this patient.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular stent are identified in d2 and g4.H10: manufacturing review: 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 stent delivery system was returned for evaluation.An x-ray image was provided which shows the distal broken-off part of the catheter, that is the marker band and the tip over the proximal undeployed section of the stent.The returned sample was fully activated and the stent was completely deployed and missing as it was reported to have been deployed in the patient.The distal part of the outer catheter including the radio-opaque marker band were broken, detached and missing which leads to confirmed result for sheath break, detachment and partial deployment of the stent.The vessel was tortuous but without calcification, there was pre-dilatation; the user felt great resistance and made multiple attempts.Based on the available information and the returned sample analysis, the investigation is closed with confirmed results for partial deployment, break and detachment.A definite root cause of the reported incident can not be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding warnings, the instructions for use states "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit".With regards to warnings, the instructions for use states "visually inspect the lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".Regarding accessories, the instructions for use states "the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the femoral route, insert a 0.035 inch (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to the procedure, the instructions for use states "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".H10: d4 (expiration date: 04/2025), g3.H11: h6 (device, method, 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 : see h10.

Event Description

It was reported that during a stent placement procedure in iliac artery, the part from the blue t-type luer fitting to the tail end was unable to be retracted and released continuously since great resistance was encountered.It was further reported that the outer sheath for stent delivery system was allegedly ruptured.Reportedly, the tip of the stent was wrapped and remained in the body of this patient.Furthermore, open surgery needed to remove the stent.Current status of the patient was unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular stent are identified in d2 and g4.H10: manufacturing review: 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 stent delivery system was returned for evaluation.An x-ray image was provided which shows the distal broken-off part of the catheter, that is the marker band and the tip over the proximal undeployed section of the stent.The stent delivery system was returned for evaluation fully activated and the stent was completely deployed and missing as it was reported to have been deployed in the patient.The distal part of the outer catheter including the radio-opaque marker band were broken, detached and missing which leads to confirmed result for sheath break, detachment and partial deployment of the stent.The vessel was tortuous but without calcification, there was pre-dilatation; the user felt great resistance and made multiple attempts.Based on the available information and the returned sample analysis, the investigation is closed with confirmed results for partial deployment, break and detachment.A definite root cause of the reported incident can not be identified.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding warnings, the instructions for use states "should unusual resistance be felt at any time during the procedure, the entire system (introducer sheath or guiding catheter and stent delivery system) should be removed as a single unit".With regards to warnings, the instructions for use states "visually inspect the lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".Regarding accessories, the instructions for use states "the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the femoral route, insert a 0.035 inch (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to the procedure, the instructions for use states "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".H10: b5, d4 (expiration date: 04/2025), g3 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.

• Brand Name: LIFESTAR 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: 17593361
• MDR Text Key: 321623571
• Report Number: 9681442-2023-00301
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 04049519006512
• UDI-Public: (01)04049519006512
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080007
• 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
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VIEL08100
• Device Lot Number: ANGR0321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 09/26/2023
• Supplement Dates FDA Received: 09/02/2023; 09/28/2023
• 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
• Patient Outcome(s): Required Intervention