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

Catalog Number 5F050401C

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Obstruction/Occlusion (2422)

Event Date 11/11/2020

Event Type  Death  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, an image and a photo were provided for review.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: 06/2023).

Event Description

It was reported that after stent implantation in popliteal artery, the delivery system was allegedly broke and totally occluded the vessel.It was further reported that increased resistance was experienced and the device was removed with excessive force, as a result more drugs was administered and resuscitation was called afterwards because of respiratory depression.Reportedly, the patient expired one day post-procedure.

Event Description

It was reported that post stent implantation in the popliteal artery, the distal 10 cm of the delivery systems catheter broke and occluded the vessel.The indication for the stent placement was a gangrene on the left limb.As reported multiple stents have been previously placed in the patients leg, which needed to be crossed to reach the target site in the popliteal artery.After placement of the stent, increased resistance was experienced when removing the delivery system; the delivery system was finally removed with excessive force.As the catheter segment remained in the vessel an acute ischemia developed.As a result more drugs were administered and resuscitation was called afterwards because of respiratory depression.As reported an amputation of the left lower limb was announced to the patient, which was previously planned.Reportedly, the patient expired one day post-procedure, even though the patient's condition had already stabilized.As confirmed by the physician there is no causal relation between the death of the patient and the intervention respectively the reported device problem.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot number.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 delivery system was returned for evaluation, and images were provided.The stent was found completely deployed and was not returned as it was placed in the patient.As reported, the distal end of the inner catheter was found to be broken.The images provided do support the description of the physician of a significantly stenosed anatomy of the patient.However, no definite causal relation to the reported device issue could be determined.In this case a system compatible 6f introducer sheath was in use.Based on the information available no indication for inadequate use of accessories were found.Based on information available and the evaluation of the sample the reported break of the inner catheter is confirmed.However, a definite root cause for the reported event could not be determined.Labeling review:in reviewing the current version of the ifu the potential issue was found addressed.The ifu states: "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' regarding stent deployment the ifu states: "do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit." in addition the ifu states: "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." h10: the catalog number identified in section d4 has not been cleared in the us but is similar to the life sent 5f vascular stent system products that are cleared in the us.The pro code and 510 k number for the life tent 5f vascular stent system products are identified in d2 and g5.H10: b5,(expiry date: 06/2023),g4 h11: h6(result and conclusion) 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.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10964544
• MDR Text Key: 220102902
• Report Number: 9681442-2020-20066
• 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
• Report Date: 12/09/2020

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: 5F050401C
• Device Lot Number: ANET2468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/28/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR