• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

US SURGICAL PUERTO RICO PROTACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Thrombosis (2100); No Code Available (3191)
Event Date 01/15/2020
Event Type  Injury  
Manufacturer Narrative

Title: laparoscopic sacrocolpopexy complication: ilio-femoral deep vein thrombosis source: correspondence / european journal of obstetrics <(>&<)> gynecology and reproductive biology 247 (2020) 257¿271 h6: patient codes-c64343 (surgical intervention). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature source of the study performed on a patient, post operative a laparoscopic sacrocolpopexy, the mesh was secured to the anterior longitudinal ligament on the promontory using 4 non-absorbable tackers. At the end of the surgery, the mesh was covered by peritoneum using the company's barbed suture. On the third postoperative day, the patient complained of swelling of the left leg. Physical examination revealed a mild pitting edema along the entire leg. A sonographic doppler study of the left leg demonstrated no evidence of dvt (deep vein thrombosis) but rather a low flow velocity in the common-femoral vein region. A computer tomography angiogram revealed a surgical tacker at the anatomic location of the left common iliac vein. Distal to the tacker, the left iliac vein was narrow and the proximal left iliac vein was extended, without evidence of a local hematoma. The patient was diagnosed with left common iliac dvt (deep vein thrombosis) and was treated with enoxaparin. On the seventh postoperative day, the patient underwent endovascular aspiration and removal of the thrombus. A stent graft was placed at the narrow vein portion with good morphological reconstruction. The subsequent day, significant clinical improvement was noted, with complete resolution of the swelling. The case describes a rare complication of sacrocolpopexy. If dvt (ilio-femoral deep vein thrombosis may result from local anatomical changes caused by tacker placement.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROTACK
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer (Section G)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key10017663
MDR Text Key189769611
Report Number2647580-2020-01459
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeIS
PMA/PMN NumberK090470
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174006
Device Catalogue Number174006
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated By Manufacturer? Yes
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: 05/01/2020 Patient Sequence Number: 1
-
-