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

Catalog Number 5F061003CS

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

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, the photo was provided for review.The investigation of the reported event is currently underway.Expiry date (04/2022).

Event Description

It was reported that during a multiple stent placement procedure to treat a long and total occluded lesion in the proximal sfa to the knee, as this device was being advanced pass the first deployed stent it allegedly got caught.Therefore, the delivery system was removed without issue.Another pta catheter was used to further post dilate the first stent, then this same delivery system was re-introduced into the patient.As the device was being advance some resistance was felt, however, the health care provider was able to successfully position the delivery system and deploy the stent.Two additional (other manufacturer) stents were then placed; an angiogram was performed after all stents were placed, and found the distal tip had allegedly detached from this delivery system.Therefore, the tip was then pinned against the vessel wall, vessel flow was fully restored, and the procedure was completed.There was no reported patient injury.

Event Description

It was reported that during a multiple stent placement procedure to treat a long and total occluded lesion in the proximal sfa to the knee, as this device was being advanced pass the first deployed stent it allegedly got caught.Therefore, the delivery system was removed without issue.Another pta catheter was used to further post dilate the first stent, then this same delivery system was re-introduced into the patient.As the device was being advance some resistance was felt, however, the health care provider was able to successfully position the delivery system and deploy the stent.An angiogram was performed after all stents were placed, and found the distal tip had allegedly detached from this delivery system.Therefore, the tip was then pinned against the vessel wall, vessel flow was fully restored, and the procedure was completed.There was no reported patient injury.

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 sample was returned for evaluation.The returned sample confirmed break and detachment of the distal inner catheter including tip.Inner catheter break was reportedly identified after deployment.Break may occur as a result of difficulty patient anatomy leading to increased friction during deployment and/ or tracking.In this case a pre dilation was performed but the user experienced repeated difficulty passing a previously placed stent leading to resistance felt on the system.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 during stent system introduction, the stent system should be withdrawn and another stent system should be used.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' in regards to pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' the instructions for use further state: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used.', and under materials required the instructions for use state: '5f (1.67 mm) or larger introducer sheath ¿ 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire' h10: d4 (expiry date: 04/2022).H11: e1, h6 (device, method, result and 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.

• Brand Name: LIFESTENT 5F VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10710898
• MDR Text Key: 212306069
• Report Number: 9681442-2020-20009
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

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: 5F061003CS
• Device Lot Number: ANER2438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 75