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

Catalog Number	PXB35-08-57-135
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The visi-pro balloon-expandable biliary stent system was received for evaluation with a 7f cordis sheath and a 0.035¿ compatible guidewire.No cine images from the procedure were received for evaluation.The 7fr sheath was back lighted to determine if any component of the visi-pro was within the sheath but no component of the visi-pro remained within the sheath.The distal tip of the sheath exhibited flaring damage consistent with a device being pulled against it.The distal end of the visi-pro was examined.The distal tip, distal marker band, and distal segment of the balloon chamber were not returned with the device.The inner guidewire lumen exhibited stretching and necking down.From the proximal balloon bond, the inner guidewire lumen distal end was approximately 155mm.The visi-pro balloon chamber on a pxb35-08-57-135 is 60mm this would indicate that the inner guidewire lumen has been stretched over 75mm.The separation face of the proximal balloon chamber segment exhibited a radial tear.The balloon chamber radial tearing and inner lumen stretching is consistent with the balloon chamber radial bursting with the balloon chamber material bunching up at the distal edge of the support sheath during withdrawal if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a visipro device with a 7f x 21cm non-mdt sheath and a 0.035 stiff angled non-medtronic guidewire for treatment of a 90% stenosed calcified/plaque lesion in the proximal left common iliac artery of diameter 8mm.Slight tortuosity and moderate calcification was reported.Ifu was followed.Device prepped without issue.Embolic protection was not used.A 6x80 evercross pre-dilation device was used.The stent was deployed with no issues noted.The visipro was used to post-dilate the stent to a slightly larger diameter.The balloon was briefly inflated to 14 atm (rated burst pressure rbp 12 atm) for approximately one second before deflation and re-positioning to the location where the burst was noticed to occur at 4 atm.The burst occurred on the third inflation as the initial inflation to deploy the stent is counted as inflation one.Upon withdrawal of the balloon, the balloon catheter became lodged in the sheath; and subsequently ripped apart causing the sheath to be exchanged for a new one.No portion of the balloon is suspected to have remained in the patient.No patient injury reported.
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: 7682375
• Report Number: 2183870-2018-00375
• Device Sequence Number: 11423940
• Product Code: FGE
• UDI-Device Identifier: 00821684036532
• UDI-Public: 00821684036532
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K061566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2021
• Device Catalogue Number: PXB35-08-57-135
• Device Lot Number: A583521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1