MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1012015-120

Device Problems Break (1069); Premature Activation (1484); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that during device preparation/flushing and prior to use, while removing the protective mandrel/sheath the stent had prematurely deployed without any manipulation of the handle.There was no patient involved.The device was not used.A different device was used to successfully complete the procedure without event.There was no reported clinically significant delay in the procedure.Returned device evaluation revealed the absolute pro stent system may have been used in the anatomy and was returned with the outer jacket torn, and both the jacket and hypotube broken and bent at the distal end of the strain relief; not in two pieces.No additional information was provided.

Manufacturer Narrative

Patient codes: 2199 labeled na.Internal file number - (b)(4).Correction: description of event, patient code: 2645-labeled na - removed, device codes: 1069-labeled, 4008-labeled - removed.Evaluation summary: visual inspections were performed on the returned device.The premature/partial deployment was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the premature deployment.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: during device advancement on the guide wire, and prior to entering the anatomy, the stent prematurely deployed.All other damage occurred during packaging for return.There was no additional information provided.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8298940
• MDR Text Key: 134861711
• Report Number: 2024168-2019-00784
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 1012015-120
• Device Lot Number: 7020761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/07/2019
• Date Manufacturer Received: 02/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70