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

Catalog Number	VIUS10120
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025).H11: section a through f ¿ the information provide 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 or Problem Description
It was reported that during a stent placement procedure, the stent was allegedly partially deployed.The procedure was completed by using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure, the stent was allegedly partially deployed.The procedure was completed by using another device.There was no reported patient injury.
Additional Manufacturer Narrative
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 not returned for evaluation but photos were provided which show the stent completely deployed and the inner catheter protruding.It is not clear when the stent became completely deployed since a partial deployment was reported which leads to inconclusive results.Based on the available information and the evaluation of the provided photos, the investigation is closed with inconclusive results for partial deployment.A definite root cause of the reported incident can not be identified.The intended placement of the device in the external iliac represents an off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding warnings, the instruction 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".Regarding accessories, the instruction for use states "the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the transhepatic route, insert a 0.035¿ (0.89 mm) guidewire under fluoroscopic guidance through the biliary stricture and into the duodenum".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to the procedure, the instruction for use states "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The instruction for use states, "the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms".H10: (expiry date: 10/2025).H11: section a through f ¿ the information provide 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.
Additional Manufacturer Narrative
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 not returned for evaluation but photos were provided which show the stent completely deployed and the inner catheter protruding.It is not clear when the stent became completely deployed since a partial deployment was reported which leads to inconclusive results.Based on the available information and the evaluation of the provided photos, the investigation is closed with inconclusive results for partial deployment.A definite root cause of the reported incident can not be identified.The intended placement of the device in the external iliac represents an off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.Regarding warnings, the instruction 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".Regarding accessories, the instruction for use states "the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the transhepatic route, insert a 0.035¿ (0.89 mm) guidewire under fluoroscopic guidance through the biliary stricture and into the duodenum".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to the procedure, the instruction for use states "pre-dilatation of the stricture with an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The instruction for use states, "the bard lifestar biliary stent system is indicated for the treatment of biliary strictures resulting from malignant neoplasms".H10: d4 (expiry date: 10/2025), g3.H11: b5.H11: section a through f ¿ the information provide 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 or Problem Description
It was reported that during a stent placement procedure in the external iliac, the stent allegedly partially deployed as the catheter did not appear to come back and the stent would not release.It was further reported that the delivery system was pulled from the patient along with the partially deployed stent.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: LIFESTAR BILIARY STENT
• Common Device Name: 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: 18212130
• Report Number: 9681442-2023-00380
• Device Sequence Number: 12598882
• Product Code: FGE
• UDI-Device Identifier: 04049519005584
• UDI-Public: (01)04049519005584
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K063532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: VIUS10120
• Device Lot Number: ANGX3842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 01/03/2024; 01/23/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/05/2024; 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown