MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM

Catalog Number 5F060401C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent system products are identified.(expiry date: 05/2020).Device pending return.

Event Description

It was reported that sometime post stent placement procedure, during treatment for the stenosis in brachiocephalic vein, the stent allegedly misaligned.It was further reported that the stent was surgically removed.The patient current status was unknown.

Manufacturer Narrative

H10: additional information was received, and it was reported that the original lot number: ancs3362 shows 25-may-2020 as expiry date which was extended to 25-may-2021 by the addition of "r" in lot number.Since the lot number with r was not added in (d4) medical device catalog due to trackwise system limitations, hence the lot number was updated as ancs3362.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 catheter sample including released stent were provided for evaluation.Both, stent and delivery system were found not bloody in good condition without damage or deformation indicating malfunction.During evaluation testing the catheter system was fully functioning.Images demonstrating the alleged misalignment were not provided which leads to inconclusive evaluation result.No indication found for a process related issue.In this case the stent was placed inside a shunt in the brachiocephalic vein which is an off label use, and which was considered a significant factor.Based on the information available the investigation is closed with inconclusive result.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 instruction for use closely describes holding and handling of the system throughout the procedure including unpacking and preparation.Further, the instruction for use contains a stent size selecting table for the stent diameter.The lifestent 5f vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (sfa) and popliteal artery.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent system products are identified in d2 and g4.H10: d4 (expiry date: 05/2021).H11: h6 (patient).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.

Event Description

It was reported that sometime post stent placement procedure, during treatment for the stenosis in brachiocephalic vein, the stent allegedly misaligned.It was further reported that the stent was surgically removed.The patient current status was unknown.

Event Description

It was reported that sometime post stent placement procedure, during treatment for the stenosis in brachiocephalic vein, the stent allegedly misaligned.It was further reported that the stent was surgically removed.The patient current status was unknown.

Manufacturer Narrative

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 catheter sample including released stent were provided for evaluation.Both, stent and delivery system were found not bloody in good condition without damage or deformation indicating malfunction.During evaluation testing the catheter system was fully functioning.Images demonstrating the alleged misalignment were not provided which leads to inconclusive evaluation result.No indication found for a process related issue.Misalignment during deployment may be related to incorrect holding or handling of the system during deployment.Incorrect oversizing of the stent may be a contributing factor.The stent was placed inside a shunt in the brachiocephalic vein which is an off label use, and which was considered a significant factor.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instruction for use closely describes holding and handling of the system throughout the procedure including unpacking and preparation.Further, the instruction for use contains a stent size selecting table for the stent diameter.The lifestent 5f vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (sfa) and popliteal artery.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent system products are identified in d2 and g4.H10: d4 (expiry date: 05/2021).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.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11222292
• MDR Text Key: 228408992
• Report Number: 9681442-2020-20173
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F060401C
• Device Lot Number: ANCS3362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention