MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number H74939180072070

Device Problems Fracture (1260); Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problems Ischemia (1942); Thrombosis (2100)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the stent partially deployed and fractured.A contralateral approach from the left femoral percutaneous was used to access the target lesion located in the highly stenosed and highly calcified right superficial femoral artery (sfa) with no particular tortuosity.Pre-dilation was performed.A 7x100mm innova stent was implanted at the distal sfa.A 7x200x75 innova¿ stent was then advanced to overlap the 7x100 innova.Stent deployment was initiated using the thumbwheel correctly.However, then the thumbwheel began to spin in endless circles after 2.5-3cm of the stent deployed.The stent deployment system did not work properly.The hand piece for releasing the pullgrip was stuck disallowing the possibility of completing the release of the partially deployed stent.The handle was opened but this maneuver did not allow complete release of the stent as it was not possible to move the middle shaft over the inner shaft.A long introducer was used to remove the stent with a portion of the stent remaining outside of the introducer.The stent fractured during removal from the femoral access.The attempts to solve the problem led to stent elongation and fracture.The distal part of the stent remained inside the superficial femoral artery.The remaining part was partially retracted into the introducer and removed with a left inguinal surgical incision.A control angiography detected thrombosis of the sfa and the high popliteal with presence of ischemia of the foot.The patient was transported into the operating room for revascularization surgery of the lower right extremity.A surgical procedure was performed to complete the removal of the stent.The revascularization of femoral popliteal axis, that they were able to obtain in the first phase of the procedure, failed.The patient was submitted to surgical bypass of the femoral popliteal and vein.However, on the morning of november 8, the bypass closed.Further surgical procedure was needed to substitute vein bypass with graft bypass.Post surgery, the patient was well, ischemia resolved, and the graft bypass was working fine.

Manufacturer Narrative

Device evaluated by mfr:returned product consisted of an innova self-expanding stent delivery system (sds) with a.014 guidewire stuck in the device.The introducer sheath used in the procedure was also returned stuck on the catheter shaft.The outer shaft, mid-shaft and the remainder of the device were checked for damage.The handle returned opened from the customer site and only half of the handle was returned.The guidewire was returned stuck in the device.The guidewire was protruding from the introducer sheath approximately 56cm and protruding from proximal end of the device 141cm.The outer sheath showed buckling at the nosecone and at 9cm from the nosecone.The mid-shaft showed a separation at the distal end of the outer sheath.The mid-shaft was also detached from the retainer clip.The partial portion of the stent was returned and damage.It was noticed that the proximal inner was kinked.No additional damage was noticed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.The innova dfu states that a stiff 0.035 in guidewire is strongly recommended for deployment of the stent, especially for tortuous anatomy and contralateral approaches.Use of undersized guidewires may lead to insufficient support of the device which can compromise stent delivery.(b)(4).

Event Description

It was reported the stent partially deployed and fractured.A contralateral approach from the left femoral percutaneous was used to access the target lesion located in the highly stenosed and highly calcified right superficial femoral artery (sfa) with no particular tortuosity.Pre-dilation was performed.A 7x100mm innova stent was implanted at the distal sfa.A 7x200x75 innova stent was then advanced to overlap the 7x100 innova.Stent deployment was initiated using the thumbwheel correctly.However, then the thumbwheel began to spin in endless circles after 2.5-3cm of the stent deployed.The stent deployment system did not work properly.The hand piece for releasing the pullgrip was stuck disallowing the possibility of completing the release of the partially deployed stent.The handle was opened but this maneuver did not allow complete release of the stent as it was not possible to move the middle shaft over the inner shaft.A long introducer was used to remove the stent with a portion of the stent remaining outside of the introducer.The stent fractured during removal from the femoral access.The attempts to solve the problem led to stent elongation and fracture.The distal part of the stent remained inside the superficial femoral artery.The remaining part was partially retracted into the introducer and removed with a left inguinal surgical incision.A control angiography detected thrombosis of the sfa and the high popliteal with presence of ischemia of the foot.The patient was transported into the operating room for revascularization surgery of the lower right extremity.A surgical procedure was performed to complete the removal of the stent.The revascularization of femoral popliteal axis, that they were able to obtain in the first phase of the procedure, failed.The patient was submitted to surgical bypass of the femoral popliteal and vein.However, on the morning of november 8, the bypass closed.Further surgical procedure was needed to substitute vein bypass with graft bypass.Post surgery, the patient was well, ischemia resolved, and the graft bypass was working fine.

• Brand Name: INNOVA¿
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7073435
• MDR Text Key: 93419386
• Report Number: 2134265-2017-11504
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/07/2017

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: 02/28/2019
• Device Model Number: H74939180072070
• Device Catalogue Number: 39180-07207
• Device Lot Number: 18978052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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: 62 YR