MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number 11003-29

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.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 heavily calcified right iliac artery.Pre-dilatation was performed with an unspecified balloon dilatation catheter.An unspecified 6f introducer sheath was used, and, though there was no air aspiration, the 7x29mm omnilink elite 35 stent delivery system (sds) was advanced to the target lesion without resistance.The stent was fully deployed at 11 atmospheres, and the balloon of the sds ruptured.During removal, the balloon felt resistance with the stent and the introducer sheath.Force was applied, and the distal portion of the balloon separated.The separated portion was removed through medical intervention and minor surgery.An unspecified covered stent was used to close the access site created for retrieval of the balloon portion.There was a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the return device.The reported balloon rupture and separation were confirmed.The difficulty removing was not confirmed as it was based on procedural circumstances.It should be noted that the omnilink elite instruction for use (ifu), states: should unusual resistance be felt at any time during either vessel / duct access or during removal of an undeployed stent, the stent delivery system and introducer sheath should be removed as a single unit.Additionally, the step of preparation of the pta catheter is listed prior to introduction of the system into the patient in ifu.In this case, the difficulties were most likely related to the anatomical conditions.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 identified no other similar incidents and/or complaints from this lot.The investigation determined that that the reported difficulties and subsequent patient effects were due to case circumstances.It is likely that the balloon rupture was the result of interaction with the heavily calcified lesion.Additionally, the resistance during removal and separation was likely the result of the ruptured balloon material catching on the introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: OMNILINK ELITE
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9473128
• MDR Text Key: 174744009
• Report Number: 2024168-2019-14536
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 11003-29
• Device Lot Number: 9051741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention