| Model Number 3.5X24 |
| Device Problems
Positioning Failure (1158); Device Dislodged or Dislocated (2923)
|
| Patient Problem
No Consequences Or Impact To Patient (2199)
|
| Event Date 10/11/2018 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
Dhr review was performed (october 15, 2018): the review of the dhr (device history record) indicates that the product was supplied meeting specifications.
|
| |
|
Event Description
|
|
Initial case description (received from cordis on oct.11, 2018): 3.5 x 24 elunir sheared off of the balloon attached to the delivery system floating inside of an extension catheter.The type of extension catheter used was a guidezilla made by boston scientific.Explanation of case:the physician at (b)(6) hospital located in (b)(6) was performing pci on a (b)(6) male.Access was 6f in the right femoral artery.The target lesion site was in a mid to distal rpda saphenous vein graft.The svg was previously stented and was totally occluded.A 6f system was utilized to perform the procedure.The guidezilla was residing in the straight proximal to mid segment of the svg.Upon advancing the 3.5 x 24 elunir to the target lesion site in the svg, the stent sheared off of the balloon inside of the guidezilla extension catheter.No negative prep was performed prior to or during advancement of the stent system.The entire stent was residing inside of the extension catheter.The physician then advanced a 2.0mm balloon through the stent just past the distal tip of the extension catheter and inflated it.While removing everything as a unit down to the sheath in the rfa, the stent embolized outside of the guidezilla system into the right profunda artery.Contralateral access in the left femoral artery was then achieved to insert a snare in an attempt to capture and remove the stent.The snare was then advanced to the floating stent in the profunda.End result: the stent was successfully captured and removed without harm to the patient.Additional information (received from cordis on oct.26, 2018): 1.The device was stored in the storeroom of the cath lab.2.The product was stored, handled and prepped according to the instructions for use (ifu).3.There was no difficulty experienced in prepping the device.4.Vessel / lesion characteristics: a.The target lesion was proximal portion of svg.B.The lesion was previously stented.C.The vessel was not tortuous.D.The device was not used for a chronic total occlusion (cto).5.During prep, the stent was not manipulated.6.The stent was properly mounted on the system when inspected prior to use.7.The sds was prepped according to ifu guidelines.8.Pre- dilation was performed with nominal pressure.9.Sheath in size 6f was used.10.Guide wire in size.014 was used.A.Guide wire brand: terumo runthrough 11.Guide catheter in size 6f al1sh was used.A.Guide catheter brand: cordis vista brite-tip 12.There were no kinks or other damages noted prior to inserting the product into the patient.13.There was no resistance/friction while inserting the delivery system through the guide catheter.14.There was no excessive force used anytime during the procedure.15.Prior to inserting the sds in the catheter, the balloon was not inflated or partially inflated.A.Negative pressure was not applied to the sds.B.The inflation device was in the neutral position when the system was being advanced/withdrawn.16.The physician did not reach the target site.17.The stent did not dislodge before reaching the target site.18.The stent dislodged when the physician pulled sds back into the extension catheter.19.The procedure completed when the target lesion site was treated with balloon angioplasty only.20.The patient was in good condition and discharged from the hospital.There was no patient injury.
|
| |
|
Manufacturer Narrative
|
|
Final report was signed on (b)(6) 2018.The overall conclusions below pertain to the elunir stent submitted under mfr report as well as to elunir stent submitted under mfr report #3003084171-2018-00054.Overall conclusions: 1.The review of the dhr (device history record) indicates that the two products were supplied meeting specifications.2.The results of devices analysis investigation and the customer report for product from lot #lnrus00130 and lot #lnrus00122 indicate that the returned products from both lots were supplied meeting specifications.3.The reported leak from stent delivery system of lot #lnrus00122 was confirmed.However, the cause/circumstances for the leak in the rx- port region are unclear.No determinant conclusion can be made as to the sequence of events that brought about the reported event.While no definite conclusion can be made as to the circumstance(s) of the reported failure, there are no signs of any product manufacturing issues.It should be noted that elunir¿ coronary stent systems undergo 100% in-line leak testing to prevent the release of products with such defects.4.The returned product from lot #lnrus00130 was received for analysis lacking the stent on the delivery system which concurs with the customer complaint.However, the circumstances leading to the reported stent dislodgement are unclear and furthermore, the absence of the stent from returned product of lot # lnrus00130 impedes the investigation.No evidence-based conclusion can be made as to the circumstances for the reported complaint.While no definite conclusion can be made as to the circumstance(s) of the reported failure, there are no signs of any product manufacturing issues.5.The angiogram was reviewed by medinol's cardiologist dr.Gidon perlman.The patient had known cad with history of cabg.According to dr.Perlman, the stent that dislodged while retrieving and that embolized into the right profunda artery was successfully snared and removed from the patient.The patient was not harmed by this event according to the best of his knowledge.6.Stent embolization is one of the potential adverse events of stenting procedures and is listed as such in section 8.3 of elunir ifu.7.The procedure was completed by treating the target lesion site with balloon angioplasty only.8.The elunir stent delivery system size 3.5x28 was removed and replaced with a different 3.5 x 28 elunir.9.The patient was discharged from the hospital and is in good condition as per the information received on oct.26, 2018 and nov.01, 2018.10.There was no injury to patient.
|
| |
|
Manufacturer Narrative
|
|
The procedural cd/angiogram was available on (b)(6)2018 and was analyzed by medinol's interventional cardiologist on (b)(6)2018.Review of angiogam: 1.Patient is post cabg and ddd pacemaker 2.Access is rfa 3.Native coronaries: occluded lad, rca and cx 4.Grafts: 2 severe lesions in graft to marginal branch, lima to lad - ok, occluded (probably cto) graft to rca (this is the graft where the stent dislodged) 5.Pci to the graft to the marginal branch is performed first 6.With the use of a guide extension 3 elunir stents are implanted successfully in the first graft 7.There no evidence of balloon burst in this first part of the procedure (re: lnrus174) 8.Next, pci to the graft to rca is performed 9.A terumo runthrough wire is used through a 6f alish guide 10.Support with a guidezilla extension catheter is also used 11.After initial predilation it is now evident that there are at least 2 long stents in the graft extending to the native pda 12.A long stent is implanted in the mid portion of the graft, proximal to the 2 old stents 13.Following this stent there is no flow in the graft (which was initially occluded) 14.A second stent, approximately 20mm long is implanted in the proximal portion of the graft, without restoration of flow.This stent appears under-expanded in its mid-portion 15.What appears to be an otw balloon is inserted to the distal graft 16.Distal injection reveals reduced flow to the native distal rca, with stenosis of the anastomosis 17.After the 2 stents were implanted, a guidezilla extension is inserted and a 3rd stent is advanced 18.This 3rd stent is probably the elunir 24x3.5mm stent 19.It looks like there is difficulty advancing the stent through the guidezilla (which is well extended into the graft), the proximal stent marker is seen in the aortic portion of the extension 20.Following that, the stent is seen dislodged from the sds inside the guidezilla 21.I cannot see the stage in which the dislocation occured, it is clear that the stent was advanced through the entire guidezilla catheter, but i cannot know if it entered the graft or rca 22.A 2.0mm balloon is inserted through the dislocated stent and inflated 23.The entire system with the wire and 2 catheters is removed with the wire well ahead of the stent 24.However, at the entrance to the 6f femoral sheath the stent is lost and it embolizes into the right profunda 25.The stent is eventually snared and extracted through the lfa 26.A balloon is used to dilate the distal graft lesion with improvement of flow through the graft to the rca, but this is still timi2 according to the interventional cardiologist expert opinion: 1.This was a complex case 2.An elunir stent was dislodged from the sds, the mechanism is unclear to me 3.The stent then embolized after being retrieved but was successfully snared and removed 4.The patient was not harmed by this event, to the best of my knowledge device analysis was performed on (b)(6)2018 with the folliwng results: results of this investigation reveal that the returned product exhibited kinks and bends.The returned product was received without a stent.The observed prominent residual stent imprinting indicates normal stent integration.It may be surmised that the observed kinks/bends are the result of post procedure handling.In the majority of cases, kinks /bends such as those observed on this system occur because of post procedure handling.Often the used products are "coiled/folded" and "thrusted" into a receptacle in a manner that leads to deformation/bends in the system.Whereas the product was returned without the stent this component cannot be investigated.The returned delivery system has been investigated and no anomalies were observed that offer any insight as to the circumstances for the reported complaint.Based on this investigation, no determinant conclusion can be made as to the sequence of events that brought about the reported complaint.However, it may be surmised that the product was supplied meeting specifications.This assumption is further supported by the customer report that "the stent was properly mounted on the system when inspected prior to use" and controls in place to prevent deformed/damaged products from being released (e.G.Sops # 907001041 and 907001077).While no definite conclusion can be made as to the circumstance(s) of the reported failure, there are no signs of any product manufacturing issues.Case-2018-00043699;medinol complaint # lnrus173 - ifu review performed on (b)(6)2018: no deviation of ifu was reported.
|
| |
|
Event Description
|
|
Additional information received from cordis on (b)(6)2018: ·elunir stent delivery system did not reach the lesion and the previously deployed stent did not contribute to stent dislodgment as the stent dislodgment occurred inside of the guidzilla guidliner support catheter.·it is unknown when the previous stent was deployed.·the previously deployed stent was deployed successfully though the brand is unknown.·at the time of the procedure, moderate to severe calcification was noted in the previously deployed stent and the location was at an acute bend in the distal svg to the rpda.·according to the physician's explanation to the clinical sales representative, the previously deployed stent was totally occluded.Medinol suspected this case (cordis case-2018-0004369, lnrus173) may have overlapped with another case (cordis case-2018-00043752).Therefore a request for clarification was sent to cordis on (b)(6)2018.Cordis reply, received on (b)(6)2018 clarified that indeed both complaints pertain to the same procedure performed on (b)(6)2018.Due to the cases overlap, an additional mdr is concurrently submitted, under lnrus173-1 (mfr report no.3003084171-2018-00054).
|
| |
|
Search Alerts/Recalls
|
|
