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

Catalog Number EX062003JL

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Positioning Failure (1158); Fracture (1260); Misfire (2532)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.

Event Description

It was reported that during a stent placement in a chronic total occlusion target lesion with severe calcification around the right superior femoral artery to the popliteal artery, the guidewire was allegedly difficult to insert in the delivery system.Reportedly, after the lesion was predilated, the delivery system was allegedly unable to advance through the proximal end of the target lesion due to severe calcification.It was further reported, that during the stent deployment attempt at the site, the delivery system could not advance any further.The health care provider felt resistance and only four centimeters of the stent was deployed and the stent could not deploy any further.After a failed attempt to completely deploy the stent using forceps, the health care provider elected to remove the device.During removal of the device, four centimeters of the stent allegedly detached from the device and remained inside the vessel.A competitor's device was deployed to address the detached part of the stent and another stent was deployed into the distal end of the target lesion.Patient's anatomy has recovered.Current patient status is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was performed.Based on the lot history review, the used product complied with all manufacturing specifications leading to final device release.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented that could have led to the event reported.No manufacturing anomalies or deviations, which may have caused or contributed to the event reported, have been identified.No additional complaint has been previously reported for this lot number.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the delivery system could only partially deploy the stent and that stent fracture occurred upon removal of the partially released delivery system/stent from the patient.It was also confirmed that the user tried to manually release the stent by dismantling the grip and pulling on inner components.A force transmitting joint was found broken which led to the conclusion that a high release force must have been present during stent release which led to partial stent deployment and stent fracture upon removal from the patient.The system was found over triggered as a consequence of the deployment failure which led to further damage.However, based on the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.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 regards to over triggering the ifu states: 'do not push the trigger after the stent is fully deployed.', however, in this case a deployment failure occurred.(b)(4).

Event Description

It was reported that during a stent placement in a chronic total occlusion target lesion with severe calcification around the right superior femoral artery to the popliteal artery, the guidewire was allegedly difficult to insert in the patient due to severe calcifications.Reportedly, after the lesion was predilated, the delivery system was allegedly unable to advance through the proximal end of the target lesion due to severe calcification.The health care provider felt resistance and only four centimeters of the stent was deployed and the stent could not deploy any further.After a failed attempt to completely deploy the stent using forceps, the health care provider elected to remove the device.During removal of the device, four centimeters of the stent allegedly detached from the device and remained inside the vessel.A competitor's device was deployed to address the detached part of the stent and another stent was deployed into the distal end of the target lesion.Patient's anatomy has recovered.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6921296
• MDR Text Key: 89022975
• Report Number: 9681442-2017-00279
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741112058
• UDI-Public: (01)00801741112058
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

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: 03/24/2019
• Device Catalogue Number: EX062003JL
• Device Lot Number: ANBQ3511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR