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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® TIGRIS® VASCULAR STENT; STENT, SUPERFICIAL FEMORAL ARTERY

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W.L. GORE & ASSOCIATES GORE® TIGRIS® VASCULAR STENT; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Catalog Number PHB051002
Device Problems Occlusion Within Device (1423); Sticking (1597)
Patient Problems Occlusion (1984); Vascular Dissection (3160)
Event Date 09/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient was presented with an occluded gore® viabahn® endoprosthesis which was implanted within the right popliteal artery approximately two years ago in another hospital.It was stated that the medical device occlusion was intended to be treated with a gore® tigris® vascular stent.It was reported to gore that the device occlusion was predialated with a 5x150 balloon and that the gore® tigris® vascular stent was inserted through a 6fr introducer sheath and advanced over a 0.035 stiff guidewire by using a cross over approach.It was stated that the patient¿s vessel itself did not indicate any calcification or tortuosity.It was reported to gore that when device deployment was initiated the stent didn¿t continue to deploy completely as the deployment wheel became stuck and couldn¿t be rotated any further.It was stated that the ¿safety catch¿ was even tried to be pulled without any success.It was reported to gore that the physician was able to retrieve the partial deployed tigris device from the patient¿s vessel through the introducer sheath, where a lot of force was required, without performing a conversion of the patient¿s leg.Consequently, as the patient¿s vessel layers were injured, the popliteal artery and superficial femoral artery occluded.A thrombectomy was performed and the lesion was treated by implanting another stent (supera stent).It was stated that the patient is doing well following the procedure and that a good blood flow was established.
 
Manufacturer Narrative
The review of the manufacturing records verified that this lot met all pre-release specifications.When physically evaluated upon return, the following observations were made: the gore® viabahn® endoprosthesis was kinked at multiple locations along the catheter, including near the strain relief.The inner shaft was flattened proximal to features.The tear tube was severed at the thumbwheel.Destructive disassembly of the outer sheath and strain relief was required to remove the tear tube from the outer sheath at the location of the strain relief.Approximately 32.5 mm of the distal end of the stent was uncovered.The coupler bond was unable to be removed without destructive removal of the outer sheath.The coupler bond appeared unremarkable.
 
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Brand Name
GORE® TIGRIS® VASCULAR STENT
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL CENTRAL B/P
1500 n. fourth street
flagstaff AZ 86004
Manufacturer Contact
barbara ulrich
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key6950236
MDR Text Key90421268
Report Number2017233-2017-00537
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
P160004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/01/2017
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
Device Operator Health Professional
Device Expiration Date11/22/2019
Device Catalogue NumberPHB051002
Device Lot Number15914248
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/13/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age48 YR
Patient Weight80
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