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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. UNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Date 05/03/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation on april 06, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the jejunum during a gastrojejunostomy procedure performed on (b)(6) 2022. The implantation site was examined with eus doppler prior to deploying the stent. During the procedure, there was difficulty creating a puncture using the axios electrocautery enhanced delivery system. The stent first flange was deployed; however, the first flange did not fully expand and moved out of its position. The stent was removed partially deployed and another axios stent was implanted to complete the procedure. Reportedly, there was bleeding noted at the puncture site which resolved without any treatment. In the physician's assessment, there was a relationship between the bleeding and the axios stent. The patient experienced bleeding at the puncture site and in the physician's assessment, there was a relationship between the bleeding and the axios stent. The patient's condition at the conclusion of the procedure was reported to be fully recovered. Note: it was reported that the axios stent was intended to be placed for a gastrojejunostomy procedure. However, per the hot axios stent and electrocautery- enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >
=
6 cm in size and walled-off necrosis >
=
6 cm in size with >
=
70% fluid content that are adherent to the gastric or bowel wall. The device is not indicated to be placed in the transgastric to jejunum.
 
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Brand NameUNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14251941
MDR Text Key290400332
Report Number1020279-2022-02056
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
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