MAUDE Adverse Event Report: COVIDIEN FORTREX 0.035 OTW PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number A35HPV05040040

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

Patient Problems Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

Approximately 5 months post index procedure ((b)(6) 2017) patient suffered avf shunt stenosis. The event was treated with non-medtronic pta of venous outflow ((b)(6) 2018). Approximately 9 months post index procedure the patient suffered shunt stenosis ((b)(6) 2018). This was treated with medication and a non mdt pta was used to treat the anastomosis ((b)(6) 2018). The event is resolved. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: on (b)(6) 2018, approx. 13 months post the index procedure, avf shunt stenosis was reported. The patient was treated with medication and the venous outflow was treated with a non-mdt pta on (b)(6) 2018. The investigator assessed the event as not related to the index device, procedure or paclitaxel medication. The patient was reported to have recovered on (b)(6) 2018. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Approximately 17 months post index procedure the patient suffered avf shunt stenosis. The event was treated with non-medtronic pta. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: final adjudication reports that the re-intervention of the target limb was not procedure related, therapy related, or device related. The revasc has been adjudicated as being clinically driven and the location access circuit. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The cec adjudicated the revascularisation as target lesion, clinically driven and related to the device but not related to the procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Approximately 21 months post procedure the patient suffered avf shunt stenosis. This was treated with medication and a non mdt pta was used to treat the in cannulation zone. The event is resolved. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction of aware date (2019-07-19) for the following information. Cec adjudicated event is related to device and revascularization as a target lesion revasc. Investigator and sponsor assessed event is not related to device, procedure and paclitaxel. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec adjudicated the event is related to device and revascularization as a target lesion revasc. Investigator and sponsor assessed event as not related to the device, procedure or paclitaxel. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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.

Event Description

The patient is a non-smoker with a medical history of hyperlipidemia, diabetes, hypertension, previous revascularization of the anastomosis, coronary heart disease and renal insufficiency. During the index procedure ((b)(6) 2017) the right venous outflow lesion in the radiocephalic arteriovenous fistula (avf) was treated with a fortrex pta balloon. Approximately 2 months post index procedure ((b)(6) 2017) the patient suffered shunt stenosis at the treated lesion. The stenosis which was treated with medication and percutaneous intervention ((b)(6) 2017). The patient recovered.

• Brand Name: FORTREX 0.035 OTW PTA BALLOON CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6950153
• MDR Text Key: 119353234
• Report Number: 2183870-2017-00447
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/19/2019
• Device Catalogue Number: A35HPV05040040
• Device Lot Number: A312609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/19/2019
• 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: 10/13/2017 Patient Sequence Number: 1