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

Catalog Number 5F050603C

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem Injury (2348)

Event Date 07/02/2019

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 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.(expiry date: 09/2020), (b)(4).

Event Description

It was reported that during treatment of the distal right superficial femoral artery via left humeral tract access, the stent was allegedly difficult to advance to the lesion and failed to deploy due to the delivery system sheath wrinkling.It was further reported that the delivery system was removed with the guidewire as one unit and that no additional stent was implanted.Additional intervention will be required to treat the lesion.

Event Description

It was reported that during treatment of the distal right superficial femoral artery via left humeral tract access, the stent was allegedly difficult to advance to the lesion, the handle loosened, and the stent failed to deploy due to the delivery system sheath wrinkling.It was further reported that the delivery system was removed with the guidewire as one unit and that no additional stent was implanted.Additional intervention will be required to treat the lesion.

Manufacturer Narrative

H10: manufacturing review: review of manufacturing records was not performed, as no additional complaint has 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.Investigation summary: based on the investigation of the returned catheter sample a deployment failure could not be confirmed because the safety lock slider was found in secured position, and because the stent was fully and correctly loaded.The system was found with compressive crinkles, with a kink and with a gap between the two grip shells which confirmed the users¿ statement that the grip loosened, and that the stent sheath wrinkled on itself.The sample was returned without guidewire so that a stuck guidewire could not be confirmed.The investigation will be closed as confirmed for material deformation.A manufacturing related cause could not be confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address this potential risk.Correct holding and handling throughout deployment were found sufficiently described.In regard to release force increase 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', and 'if resistance is met during stent system introduction, the stent system should be withdrawn, and another stent system should be used.' in regard to pta the ifu states: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' the ifu states that the safety lock slider must be unlocked before use by pulling it back towards the wheels, and that the system requires flushing prior to use.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.H10: d4 (expiry date: 09/2020), h6(device code: 2976 - material deformation).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; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8847736
• MDR Text Key: 152860975
• Report Number: 9681442-2019-00140
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119897
• UDI-Public: (01)00801741119897
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5F050603C
• Device Lot Number: ANCW0640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention