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

Catalog Number 1012535-100

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was performed to treat a lesion in the right external iliac artery with no tortuosity and no calcification.A 7.0 x 100 mm absolute pro self - expanding stent system (sess) was advanced to the lesion via a radial approach and the stent was successfully deployed.On removal of the sess, resistance with the 6f sheath was met.Force was applied and the sess was removed independently; however the shaft was noted to have accordioned.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: visual, dimensional and functional inspection was performed on the returned device.The difficulty removing, and shaft damage was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.The absolute pro instruction for use (ifu) states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.In this case, the force applied to remove the device was due to case related circumstances.The investigation determined that the reported difficulties were due to case circumstances.It is likely due to anatomical conditions, the clearance between the absolute pro delivery system and the introducer sheath was reduced causing resistance and ultimately resulting in the devices becoming frozen together.When force was applied, it is likely that the shaft bunched as noted on the returned product.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 8683857
• MDR Text Key: 147504651
• Report Number: 2024168-2019-04548
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 1012535-100
• Device Lot Number: 7120461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2019
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F INTRODUCER SHEATH; 6F INTRODUCER SHEATH