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

Catalog Number 5F061203C

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation 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 510 k number and pro code for the lifestent 5f vascular stent system products.

Event Description

It was reported that during a stent placement procedure in the right popliteal artery via access through the right common femoral artery antegrade, after deploying the stent, the healthcare professional attempted to pull back the catheter out of the sheath but had to use excessive force.It was further reported that the proximal end of the catheter allegedly broke (approximately 15 cm) and detached in the superficial femoral artery.Reportedly, a gooseneck device was used to retrieve a portion of the segment through the sheath; however, the second segment was cut into additional fragments.Two fragments were removed via open surgery, and two other fragments were apposed to the vessel wall using additional stents.A remaining fragment was left in the patient and pushed into a small trunk of the closed fibularis artery, and it does not pose as a health hazard to the patient.The patient was reportedly stable post procedure and is recovering.

Manufacturer Narrative

Manufacturing review:the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: based on the investigation of the returned sample a break of the inner catheter at the distal end could be confirmed.The system was returned in activated state without stent as the stent had been released inside patient.The distal end of the inner catheter was found broken and four fragments of the inner catheter were part of the sample return, as reported.An indication for a manufacturing related issue could not be found.Based on the information available a definite root cause could not be identified.Labeling review: in reviewing the relevant ifu the potential issue was found addressed.The ifu state: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' regarding deployment force 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.' under materials required the ifu state '5f (1.67 mm) or larger introducer sheath', and '0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire'.The ifu 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.' in this case system compatible introducer and guidewire were being used.

Event Description

It was reported that during a stent placement procedure in the right popliteal artery via access through the right common femoral artery antegrade, after deploying the stent, the healthcare professional attempted to pull back the catheter out of the sheath but had to use excessive force.It was further reported that the proximal end of the catheter allegedly broke (approximately 15 cm) and detached in the superficial femoral artery.Reportedly, a gooseneck device was used to retrieve a portion of the segment through the sheath; however, the second segment was cut into additional fragments.Two fragments were removed via open surgery, and two other fragments were aposed to the vessel wall using additional stents.A remaining fragment was left in the patient and pushed into a small trunk of the closed fibularis artery, and it does not pose as a health hazard to the patient.The patient was reportedly stable post procedure and is recovering.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9338808
• MDR Text Key: 168044822
• Report Number: 9681442-2019-00222
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120107
• UDI-Public: (01)00801741120107
• 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: 12/16/2019

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 Expiration Date: 05/10/2021
• Device Catalogue Number: 5F061203C
• Device Lot Number: ANDS1251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/18/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention