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

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.

Manufacturer Narrative

H3, h6.The devices were not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no further information will be provided.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, procedural/user error/variance, surgical/post operative complications, healing issues, size of device and/or patient condition.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual products involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNKN TRIGEN META-TAN TROCH ANTEGR NAIL IMPL
• Type of Device: ROD, 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 Key: 14251941
• MDR Text Key: 290400332
• Report Number: 1020279-2022-02056
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• 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 Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• 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): Other