MAUDE Adverse Event Report: COOK INC

Device Problems Difficult to Fold, Unfold or Collapse (1254); Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 04/10/2018

Event Type  Injury  

Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Concomitant products: cook balloon (diameter, 8mm; length, 40mm; atb5-35-40-8-4.0) pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.Hindawi, gastroenterology research and practice volume 2018, article id: 6527879, 10 pages, https://doi.Org/10.1155/2018/6527879.

Event Description

A journal article was reviewed, "self-expanding metallic stent fracture in the treatment of malignant biliary obstruction" which retrospectively assessed the clinical features of biliary stent fractures and evaluated associated factors in one hundred fifty-six patients.Six patients' events were chronicled in the article.This report discusses the incomplete dilation and fracture of a cook inc.Self expanding metal stent (sems) used to treat a malignant biliary obstruction (mbo) in a sixty-two-year-old male patient with a medical history of pancreatic carcinoma whose common bile duct was severely obstructed by compression from the pancreatic head.On an unknown date, the patient underwent a contrast medium injection procedure via the percutaneous transhepatic approach which showed a severe obstruction of the common bile duct (cbd).Five weeks later, a biliary stent (diameter, 10mm; length, 80mm; cook inc., bloomington, in, united states) was deployed in the distal cbd.The distal part of the stent protruded into the duodenum.Because of incomplete dilation of the biliary stent, a balloon was used for biliary-plasty.Eighty-nine days after stent placement, a left percutaneous transhepatic drainage catheter was required to be placed for recurrent biliary obstruction.Cholangiography showed the biliary stent completely fractured at the level of the stricture.The study concluded ¿stent fractures following mbo treatment constitute a relatively rare, long-term complication.Though there were no factors found to be significantly associated with semss fracture, a trend could be observed towards more fractures in multistent, transpapillary, and balloon dilation groups.¿ neither product nor lot number of the complaint device has been provided.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.Please refer to medwatches with manufacturer report numbers as follows for the other cases reported in the journal article: 1820334-2018-02464; 1820334-2018-02500; 1820334-2018-02502; 1820334-2018-02503; 1820334-2018-02504.

Manufacturer Narrative

Investigation - evaluation: a review of the instructions for use (ifu), manufacturing instructions, and specifications was conducted during the investigation.A review of provided images was also conducted.The imaging review of the relevant images provided evidence of repetitive stress on the stent struts.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, the conclusion of this investigation is that a combination of forces (contraction at the ampulla of vater, as well as an abrupt change in forces as the stent extended out into the duodenum and the perpendicular direction of peristalsis experienced in the duodenum) likely contributed to metal fatigue and eventual fracture.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7813101
• MDR Text Key: 118145144
• Report Number: 1820334-2018-02501
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR