MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number EVX35-06-150-080

Device Problem Fracture (1260)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use an everflex entrust to treat two lesions in the superficial femoral artery (sfa).The first 2cm lesion was in the proximal sfa, with 70% stenosis.The second 20cm lesion in the mid and distal superficial femoral artery (sfa).A terumo destination 6fr sheath and an amplatz 0.035 guidewire was used in the procedure.No embolic protection used.The device was prepped per ifu with no issues.There was no damage noted to the packaging.There was no damage to the deployment mechanisms or device handle prior to deployment.Resistance was encountered while advancing the device but no excessive force was used.The physician pushed the catheter forward to the lesion.It was reported that during deployment of the stent, a stent fracture occurred.After release of the stent, the thumbwheel blocked and the physician attempted to retrieve the stent and failed.The physician pulled back the catheter with the partially deployed stent and it was noticed that the stent was stretched and broken.Part of the stent was removed but 5-7cm of the stent remained in the patient¿s vessel.Another stent was used to cage the detached portion of the everflex entrust stent to the patient¿s vessel wall and this stent was post dilated.It was reported that the broken stent and remaining stent fragments may have caused a retrograde dissection of the vessel.Post procedure, there was restenosis of the proximal lesion and instant stenosis of the second lesion.Lysis of the sfa and a (b)(6) infection was reported and the patient received intravenous antibiotics for four weeks.

Manufacturer Narrative

Additional information: the everflex entrust stent delivery system, (sds), was not received for evaluation.No ancillary devices from the procedure were received for evaluation.Eleven photographic images were received for evaluation.The first ten photographic images are of cine images.Images 1, 2, and 4 are of the proximal end of the superficial femoral artery.The images confirm the presence of a lesion in the area.Image 3 is of the same vessel anatomy with a stent successfully implanted.Images 5 and 6 are of the superficial femoral artery just above the knee.The vessel shows minimal tortuosity and the lesions appear to be calcified.Images 7-10 are of the same vessel anatomy after a stent has been implanted.The implanted stent shows signs of radial compression of the stent in the areas of the calcified lesions observed in images 5 and 6.The eleventh photographic image is of the distal end of an entrust stent delivery system.A single half row of stent is observed protruding from the distal end of the delivery system outer sheath.The exposed stent cell exhibits a tensile fracture face.The guidewire in the image appears to be a stiff 0.035¿ guidewire.The guidewire exhibits several bends/kinks.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation: the everflex entrust sds was received within a white plastic bag, and loose nested in a plastic pouch.The entrust was received loaded on a blue guidewire.The guidewire was very stiff and bent in a curve near its distal end.The guidewire did not protrude from the proximal end of the entrust.Approximately two stent rows were protruding from the distal tip of the entrust sds outer sheath.The stent cell rows exhibit stretching/elongation and tensile fracture.The entrust sds deployment handle was inspected.The inner guidewire lumen did not exhibit any kinking or accordion folding within the handle¿s safety tab cavity.The pull cable was not present in the safety tab cavity, indicating that the pull cable had separated from the outer sheath.With the pull cable broken the outer sheath was free to slide distally while the entrust was removed from the patient.The deployment handle¿s thumbwheel was noted to be able to move freely.The stiff guidewire was determined to be a 0.035¿ compatible guidewire.The guidewire exhibited permanent deformation which caused its profile measurement to be larger than expected.The printed strain relief/isolation sheath was slid distally to allow further analysis of the entrust sds handle.A zone of accordion folding of the inner guidewire lumen was noted under the isolation sheath.The deployment handle was split opened and the guidewire was wound around the thumbwheel.The handle was examined for pull cable witness marks; no unusual wear witness marks were note in the deployment handle.The absence of unusual wear marks indicate that the pull cable was properly routed.A zone of accordion folding of the inner guidewire lumen was noted near the proximal hub luer.A set of double kinks were note in the inner guidewire lumen, approximately 17.2cm and 17.6cm distal of the proximal hub.The zone of accordion folding that was under the isolation is located approximately 21.2 cm and runs to 22.9cm distal of the proximal hub.The proximal hub was cut off to allow further examination of the entrust catheter.The isolation sheath was slid proximally over the inner guidewire lumen to allow further examination of the entrust catheter.The proximal end of the outer sheath was located approximately 91.4cm from the proximal end of the inner guidewire lumen.The pull cable appears to remain weaved into the outer sheath.The pull cable appears to have separated proximal to the proximal end of the outer sheath, under tensile force.A large radius bend is present in the catheter from approximately 120.5cm to 137.0 cm from the proximal end of the inner guidewire lumen.A second large radius bend is present in the catheter from approximately 140.0cm to 147.0cm, from the proximal end of the inner guidewire lumen.A smaller radius bend is present in the catheter from approximately 165.0cm to 173.0 cm, from the proximal end of the inner guidewire lumen.Due to the bends in the catheter it was not possible to get an accurate length measurement, of the distal tip to proximal end of the outer sheath.By pinning the proximal end of the inner guidewire lumen proximal of the outer sheath and pulling on the guidewire the stent was able to be deployed.Approximately 137mm of the 150mm stent were returned within the entrust sds.The stiff 0.035¿ compatible guidewire exhibited a large radius bend approximately 111.0cm to 122.0cm from the proximal end of the guidewire.A smaller radius curve was noted approximately 145.0cm to 156.0cm from the proximal end of the guidewire.A ¿s¿ bend was noted approximately 161.0cm to 168.0cm from the proximal end of the guidewire.Due to the bends in the guidewire an accurate length measurement of the guidewire could not be taken.With the guidewire removed from the catheter the previously noted bends are not present in the sds catheter.The bends in the guidewire appear to be permanent deformations and the likely source of the bends in the entrust sds catheter.The bends in the catheter would affect the performance of the entrust sds to fully deploy the stent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: proximal lesion was reported as being a soft tissue lesion.It was 6 days post procedure when the instent restenosis sfa (distal lesion) and occlusion of the proximal sfa lesion, with signs of infection (staph.Aureus in blood culture) were diagnosed.Patient was treated with local thrombolysis overnight.One day post thrombolysis the patient¿s sfa and peripheral vessels are reported as being open again.Sepsis reported 4 days post vessels being reported as open.Instent restenosis, clinical, long-segment inflammation of the sfa vessel wall is also reported.Following removal of the stent fragments, no further interventional treatment was carried out due to systemic infection and no vital threatening of the patient¿s limbs.No pathology carried out, only laboratory with blood cultures.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8280858
• MDR Text Key: 134182341
• Report Number: 2183870-2019-00037
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110023
• 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,Followup,Followup
• Report Date: 04/12/2019

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: 05/07/2021
• Device Catalogue Number: EVX35-06-150-080
• Device Lot Number: A641982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 02/06/2019; 03/06/2019; 04/05/2019
• Supplement Dates FDA Received: 03/04/2019; 03/21/2019; 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2018
• 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: 62 YR
• Patient Weight: 90