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

Catalog Number 5F051203C

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

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 06/28/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device is pending return.The investigation is currently underway.The catalog number identified has not been cleared in the u.S.But, it 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 are identified respectively.

Event Description

It was reported that during treatment of the right superficial femoral artery via left common femoral artery access, the distal segment of the delivery system allegedly broke, detached, and was left near the iliac and common femoral artery.It was further reported that the segment was removed with forceps via a second intervention through an endovascular approach.The patient was reportedly stable at the conclusion of the procedure.

Event Description

It was reported that during treatment of the right superficial femoral artery via left common femoral artery access, the distal segment of the delivery system allegedly broke, detached, and was left near the iliac and common femoral artery.It was further reported that the healthcare provider (hcp) planned to remove the segment with forceps in a second intervention through an endovascular approach; however, the device would have broken into small segments and the hcp chose to perform a surgical removal instead.The patient was reportedly stable at the conclusion of the procedure.

Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: based on the investigation of images provided a break of the inner lumen could be confirmed.Two images provided demonstrated the broken and separated inner lumen on the table, after the event.On one image it consisted of one piece, on the other image it consisted of 4 pieces.It was concluded that these breaks were caused after the event.Reportedly, the inner catheter broke in small parts during the attempt to remove it from the patient, however, images of the small parts/ removal were not provided.The physical sample was not available.The investigation will be closed as confirmed.A manufacturing related issue could not be identified based on images provided.Labeling review: in reviewing the relevant ifu for this product 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.' the ifu further 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.' 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.'.Regarding pta the ifu states: ¿pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' the catalog number identified in section d4 has not been cleared in the u.S.But, it 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 are identified in d2 and g5 respectively.(methods, results, conclusion).

Manufacturer Narrative

H10: manufacturing review: the lot number was provided and the lot device history records have been reviewed.The 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 returned delivery system fragments and images provided a break of the inner lumen could be confirmed.Images documenting the break / fragments inside patient have not been provided.The investigation will be closed as confirmed for inner catheter break.A manufacturing related issue could not be identified.Based on the investigation the reported issue was closed as confirmed for inner catheter break.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant ifu for this product 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.' the ifu further 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.' 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.'.Regarding pta the ifu states: ¿pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' h10: the catalog number identified in section d4 has not been cleared in the u.S.But, it 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 are identified in d2 and g5 respectively.H10: g4, d4(expiry date: 12/2019).H11: d2, d10, g1, h3, h6(methods).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 during treatment of the right superficial femoral artery via left common femoral artery access, the distal segment of the delivery system allegedly broke, detached, and was left near the iliac and common femoral artery.It was further reported that the healthcare provider (hcp) planned to remove the segment with forceps in a second intervention through an endovascular approach; however, the device would have broken into small segments and the hcp chose to perform a surgical removal instead.The patient was reportedly stable at the conclusion of the procedure.

• 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: 8824572
• MDR Text Key: 152170181
• Report Number: 9681442-2019-00138
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119927
• UDI-Public: (01)00801741119927
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: 5F051203C
• Device Lot Number: ANBZ2434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention