MAUDE Adverse Event Report: ENDOLOGIX, INC. POWERLINK SYSTEM; INFRARENAL BIFURCATED STENT GRAFT

Model Number 25-16-155BL

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Retraction Problem (1536); Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that during the initial implant of a bifurcated device there were difficulties deploying the contralateral limb.During deployment of the contralateral limb, the surepass wire was attempted to be pulled back.However, the wire was stuck before the body sheath gains entry into the 14-fr dryseal sheath.Changing the position of the tip of the sheath, the pulling-back was reattempted but failed.After a trial-and-error, only the surepass wire came off.Thus the contralateral limb could not be deployed and the body sheath remained in the vessel.A 4-fr kmp was inserted from a brachial artery and brought forward.A 0.014'' wire was inserted through the kmp into the undeployed contralateral limb.Then the dilatation of the limb was attempted with a pta balloon but failed.Thus a groin incision was performed and the body sheath was retrieved with forceps.The retrieval of the sock (the cover of the contralateral limb) was attempted with a snare catheter because forceps could not reach the sock.However, the retrieval failed.In priority to further attempt, a competitor device ((b)(4) cuff 28 x 70) was placed just under the renal arteries.Further extension of the groin incision was performed.Then the sock was retrieved with forceps.Ballooning in both right and light common iliac arteries was performed.No endoleak was observed.The procedure was successfully completed.The patient is recovering.

Manufacturer Narrative

Endologix continues to investigate the reported event.Endologix will submit a supplemental report in accordance with 21 cfr 803.56 when additional information becomes available.Device remains implanted in patient.

Manufacturer Narrative

Based upon the investigation, the reported difficulty was confirmed.The returned device examination showed that the release sleeve had been torn during deployment.No medical documentation and suboptimal imaging studies were available for this review.Product use was incongruent with the ifu due to: bilateral iliac artery diameters greater than 2.3 cm; and, a (b)(4) change in the aortic neck diameter.Cautionary product use conditions that might have contributed to this event included: a severely calcified, mildly aneurysmal aorto-iliac system with two areas of approx.1.5 cm focal stenoses with near circumferential calcifications.One stenosis was observed just above the bifurcation.At implant, there was evidence to support a non-deployed contralateral limb stent and an eventual successful deployment of the bifurcated stent.The reported miscellaneous issue of an additional arterial access and foreign body retrieval of the release sleeve could not be established due to lack of information.The technical success or the final patient disposition could also not be established due to lack of information.A manufacturing record review was performed, the lot met all release criteria with no issues or deviations that would explain the reported event.The lot usage history showed all units have been consumed and no other units from this lot were involved in any similar event.The product labeling was reviewed and confirmed that the reported event is adequately captured in the existing labeling.The root cause of the deployment difficulty could not be identified.The clinical review showed off-label use of the device that included severely calcified, mildly aneurysmal aorto-iliac system with two areas of approx.1.5 cm focal stenoses with near circumferential calcifications, which has the potential to cause deployment difficulty.The clinical review had limited information to assess, but the cause of the deployment difficulty could not be determined.The return analysis showed what appeared to be excessive force exerted during the deployment attempt, which ripped the stent covers during removal, but the restriction that caused the deployment resistance could not be determined from the return analysis.The incident description was not fully clear, but it suggested that the non-endologix blue introducer, that was returned, may have been a factor.There was no evident anomaly with the blue introducer although device compatibility under the conditions of use may have contributed to the event or been the cause of the event.It is unknown if the returned non-endologix introducer met specification requirements or if it was applicable for use.

• Brand Name: POWERLINK SYSTEM
• Type of Device: INFRARENAL BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: elsa ibarbol ; 2 musick; irvine, CA 92618 ; 9495984719
• MDR Report Key: 4754673
• MDR Text Key: 16853910
• Report Number: 2031527-2015-00110
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2015
• Device Model Number: 25-16-155BL
• Device Lot Number: 1062541-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 05/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2013
• 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 Age: 70 YR