MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number AB35W05080135

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

Patient Problems Death (1802); Stenosis (2263)

Event Date 12/15/2014

Event Type  Death  

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

On (b)(6) 2014, subject underwent intervention of a 40 mm, (b)(4) stenotic lesion in the left proximal sfa.The lesion was predilated with a 4 mm pta balloon at 10 atm resulting in a (b)(4) residual stenosis.The subject was then randomized to a bare balloon.The study balloon was inflated to 10 atm for 3 minutes with a 0% residual stenosis.No complications occurred during the procedure and the subject was discharged per plan on (b)(6) 2014.The subject completed all required study follow-up visits through 24 months, with the last visit occurring on (b)(6) 2016.On (b)(6) 2015, the subject received a diagnosis of suspected pancreatic cancer.Surgery was refused.Biliary stent was implanted ( date unknown).On (b)(6) 2015, it was noted that the target lesion had restenosis (left proximal sfa).On (b)(6) 2016 the subject underwent a revascularization procedure with pta to treat the restenosis of the target lesion.The subject was hospitalized with cholangiosepsis on (b)(6) 2016 and a secondary biliary stent was implanted as the first was occluded.On (b)(6) 2017 the subject was hospitalized for complaint of epigastric pain and significant tumor progression was noted.On (b)(6) 2017 the subject was hospitalized with suspected peritoneal carcinoma.On (b)(6) 2017 the clinical site became aware that the subject had died on (b)(6) 2017.Per the site, the cause of death is known pancreatic carcinoma (advanced); paralytic ileus and metabolic derailment.The physician does not believe that the device malfunction is the contributory cause for the death.

• Brand Name: EVERCROSS 035
• 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: 6847546
• MDR Text Key: 85078403
• Report Number: 2183870-2017-00381
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2016
• Device Model Number: AB35W05080135
• Device Catalogue Number: AB35W05080135
• Device Lot Number: 9752511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Date Device Manufactured: 05/28/2013
• 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): Death; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 47