MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC PLUS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNK-CV-GWY-PCP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 06/02/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During revascularization of the target lesion a pacific plus pta and four in.Pact pacific paclitaxel eluting balloon catheters were used.During a second revascularisation of the target lesion an amphirion deep pta and an in.Pact pacific paclitaxel eluting balloon catheter were used.During a third revascularization of the target lesion, an admiral xtreme pta and an in.Pact pacific paclitaxel eluting balloon catheter were used.During a fourth revascularization of the target lesion an amphirion deep pta and two in.Pact pacific paclitaxel eluting balloon catheters were used.Approximately 21 months post first revascularization, 16 months post second revascularization, 13 months post third revascularization and 8 months post fourth revascularization patient suffered re occlusion of the left sfa and popliteal (target lesion) and was treated with surgical intervention (bypass).Patient recovered.

Manufacturer Narrative

The surgical intervention (bypass) was performed approx 5 days post the occlusion event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Following bypass surgery, the lesion occluded.The patient was further treated approximately five months later with deb to the left sfa.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Manufacturing site address updated.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: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av.paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 7529001
• MDR Text Key: 108722019
• Report Number: 3004066202-2018-00025
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-CV-GWY-PCP
• Device Catalogue Number: UNK-CV-GWY-PCP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 86