MAUDE Adverse Event Report: COOK INC FORMULA 535 VASCULAR BALLOON-EXPANDABLE STENT

Catalog Number FOV535-35-135-7-20

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 07/19/2018

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, or unavailable.Common name & product code = unavailable as the device is not cleared for marketing in the united states; however, same/similar device is cleared.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, during stenting of the right iliac artery, the stent portion of the formula 535 vascular balloon-expandable stent slipped out from the balloon in the direction of the catheter.This occurred while positioning the stent.A second formula 535 vascular balloon-expandable stent was utilized; however, the same issue occurred.This second stent migrated in the direction of the patient's vessel.Arterial spasm was denied.Reportedly, the complaint devices were being placed through a cook introducer.The second complaint device was surgically removed during a scheduled bypass procedure.Per the complainant, the patient is "fine.".

Manufacturer Narrative

Investigation evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a representative device returned by the complainant used during the same procedure from the same lot was examined.Additionally, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.During the analysis of the representative device, the device passed all relevant design outputs.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there was one other reported complaint for this lot number.Based on the information provided, examination of the representative product, and the results of our investigation, a definite root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

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

• Brand Name: FORMULA 535 VASCULAR BALLOON-EXPANDABLE STENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7812506
• MDR Text Key: 118110322
• Report Number: 1820334-2018-02428
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 10827002567969
• UDI-Public: (01)10827002567969(17)210301(10)8634168
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

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
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: FOV535-35-135-7-20
• Device Lot Number: 8634168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK INTRODUCER; COOK INTRODUCER
• Patient Outcome(s): Required Intervention