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

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.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the photographs provided were from a literature study.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).It was reported that the patient had experienced a medical complication as a result of device usage.The reported issue was confirmed.The most likely root cause could not be established from the information available.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not use the instrument on tissue(s) which cannot be inspected visually for hemostasis.A minimum of 4 mm tissue thickness is required when applying the helical fastener over underlying bone, vessels, or viscera.This device should not be used in tissues that have a direct anatomic relationship to major vascular structures.This would include the deployment of helical fasteners in the diaphragm in the vicinity of the pericardium, aorta or inferior vena cava during diaphragmatic hernia repair.Do not use in ischemic or necrotic tissue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTACK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 10017663
• MDR Text Key: 189769611
• Report Number: 2647580-2020-01459
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521070400
• UDI-Public: 10884521070400
• Combination Product (y/n): N
• PMA/PMN Number: K090470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• 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 Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174006
• Device Catalogue Number: 174006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR