MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PXB35-08-57-135
Medical Device Problem Codes	Burst Container or Vessel (1074); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Codes	Stroke/CVA (1770); Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician intended to use a visi-pro stent during procedure for treatment of the left mid common iliac artery.The calcified lesion exhibited little tortuosity and moderate calcification with cto 100% stenosis.Lesion length was reported as 50mm and artery diameter was 9mm.A 6f x 90cm sheath was placed in the brachial artery.Physician crossed the cto of common iliac and external iliac with a.035 glidewire and.035 catheter.Physician predilated lesion with multiple inflations with a 6x150 evercross balloon.Embolic protection was not used.Physician then placed an 8x150x150 everflex entrust into the external iliac and extending into the common iliac.An area of approximate 9x50mm was left and physician attempted to deploy the 8x57x135 visi-pro stent.There was no damage noted to the packaging of the device.There was no issue when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.Excessive force was not used.The proximal 2/3 of the stent began to deploy correctly.The distal 1.3 of the stent was not deploying.X-ray tech noted that they were having trouble maintaining pressure in the indeflator.The last 3-4 mm of the stent partially deployed leaving an undeployed area of stent.Upon attempting to remove the balloon the stent was pulled into the distal aorta.It is reported that stent dislodgement occurred during removal following failed delivery.The physician was able to remove the balloon leaving the stent free floating in the distal aorta.Damage to the sheath and glidewire were noticed.Physician switched out sheath and wire for new.Physican made multiple attempts to push the stent into the iliac artery with a 6f mpa catheter.The dislodged stent was pushed into right external iliac artery with a 6 f mpa catheter and then a wire was passed through the stent and the stent was dilated with a 5x60 balloon and a 10 x 40 balloon.Then a left femoral access was performed a 7f short sheath was placed.The physician accessed the right femoral artery and used an 8x40mm everflex balloon to keep the stent from moving while the phy sician wired through the stent.A.035 glidewire crossed the lesion.Physician ballooned the stent in right external iliac artery with a 5x60 balloon and a 10 x40 balloon.Physician placed a 9x57 stent in the left common iliac to complete the procedure.It is reported that a balloon burst/leak (pin hole) occurred during visi-pro stent deployment.An inflation device was used to inflate the balloon.Balloon inflation difficulties occurred during stent deployment.The device was inflated to approximately 12 atm but the inflation device could not hold pressure.Contrast ran out of inflation device.It is reported that it appears as if a hole was in the balloon in the area about 2/3 down the balloon.One inflation was applied to the device prior to the issue occurring.The stent needed to be post dilated with another balloon.The stent was implanted.Case duration was reported as 9.30 to 12.00.A stroke alert was called approximately 6 hours after completion of the case.Patient was transferred to radiology for a ct scan.Physician stated that there is no way possible that embolization could have went to brain from the area of distal aorta and iliac where the stent was.Additional information received indicated that it was confirmed that the patient had a stroke of the ophthalmic artery.Patient was discharged 48 hours post procedure and is doing well according to the physician.
Additional Manufacturer Narrative
Cine image review: six photographs of cines were received for evaluation.Cine 1 is of a support catheter in the targeted vessel with an injection of contrast flowing through the vessel.Cine 2 is of a guidewire in the targeted vessel.The vessel in the cine exhibits calcification and some degree of tortuosity.Cine 3 exhibits a free floating partially deployed stent in the right external iliac artery.The proximal end of the stent exhibits total expansion.Approximately two-thirds of the proximal end of the stent exhibit even expansion.Approximately one-third of the stent exhibits uneven or little expansion.Cine 4 exhibits the balloon expandable stent fully expanded in the vessel.Cine 5 exhibits a guidewire running through the left common iliac.Cine 6 exhibits a non-medtronic stent implanted in the left common iliac.Evaluation summary: the visi-pro balloon-expandable biliary stent system was received for evaluation.The metal wire from the support catheter was wrapped around the balloon and guidewire.The balloon chamber contained sanguine colored fluid.A 10cc water filled syringe was attached to the inflation luer lock on the y-manifold.The syringe was manually pressurized and a pinhole leak in the balloon chamber was noted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6348641
• Report Number: 2183870-2017-00079
• Device Sequence Number: 13686214
• Product Code: FGE
• UDI-Device Identifier: 00821684036532
• UDI-Public: 00821684036532
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/08/2019
• Device Catalogue Number: PXB35-08-57-135
• Device Lot Number: A323733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; 02/22/2017
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 03/22/2017; 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 113