MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number H74939295601570

Device Problems Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that partial stent deployment and stent elongation occurred.A patient with a previous right leg amputation presented with a left leg occlusion in the superficial femoral artery (sfa).The 20cm long tasc d target lesion was located in the moderately tortuous and moderate to severely calcified iliac and moderately calcified left superficial femoral artery (sfa).Vascular access was obtained from the right groin and a 6fr introducer sheath and.035 guidewire were advanced contralateral over the acute angled bifurcation and down to the occlusion.Following pre-dilation, a 120cm eluvia was advanced and deployed successfully in the distal occlusion.A 6 x 150 x 75 eluvia drug-eluting vascular stent system was then selected and advanced to the occlusion.After approximately 3cm of the stent being deployed, the thumbwheel jammed and would not deploy the rest of the stent.The handle was dismantled by the physician to try to deploy the rest of the stent; however this was not successful.The stent stretched as a result of the deployment issues.The patient was taken for surgical intervention.The stent was removed during surgery.During removal, the stent fractured.The patient had an endarterectomy followed by two additional eluvia stents placed successfully to complete the procedure.There were no further patient complications.The patient¿s condition was reported as well, pain free, warm foot and was pleased with the procedure.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an eluvia self-expanding stent delivery system (sds).A.035 guidewire was returned with the device.An introducer sheath was also returned with the device.The outer shaft, mid-shaft, proximal liner and the remainder of the device were checked for damage.The handle was previously opened when received.Visual examination showed that the outer sheath had multiple kinks throughout.The mid-shaft, inner liner and the proximal inner were all detached.The proximal inner showed multiple kinks.The inner liner showed multiple kinks.The mid-shaft was detached from the retainer clip.The mid-shaft was also stuck in the returned introducer sheath.The inner liner was detached from the clip.The pull rack showed no damage.The thumbwheel showed no damage.The stent was returned and the damage was confirmed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that partial stent deployment and stent elongation occurred.A patient with a previous right leg amputation presented with a left leg occlusion in the superficial femoral artery (sfa).The 20cm long tasc d target lesion was located in the moderately tortuous and moderate to severely calcified iliac and moderately calcified left superficial femoral artery (sfa).Vascular access was obtained from the right groin and a 6fr introducer sheath and.035 guidewire were advanced contralateral over the acute angled bifurcation and down to the occlusion.Following pre-dilation, a 120cm eluvia was advanced and deployed successfully in the distal occlusion.A 6 x 150 x 75 eluvia¿ drug-eluting vascular stent system was then selected and advanced to the occlusion.After approximately 3cm of the stent being deployed, the thumbwheel jammed and would not deploy the rest of the stent.The handle was dismantled by the physician to try to deploy the rest of the stent; however this was not successful.The stent stretched as a result of the deployment issues.The patient was taken for surgical intervention.The stent was removed during surgery.During removal, the stent fractured.The patient had an endarterectomy followed by two additional eluvia stents placed successfully to complete the procedure.There were no further patient complications.The patient¿s condition was reported as well, pain free, warm foot and was pleased with the procedure.

• Brand Name: ELUVIA¿ DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6988824
• MDR Text Key: 90626332
• Report Number: 2134265-2017-10512
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2018
• Device Model Number: H74939295601570
• Device Catalogue Number: 39295-60157
• Device Lot Number: 20749451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 92169170-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR