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

Catalog Number 11013-19

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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 complaints.Based on the information provided, the reported difficulties and subsequent treatments appear to be due to case circumstances.It is likely that the balloon refolds, and profile became compromised post stent deployment due to interaction with the anatomy and/or stent during removal resulting in the balloon material becoming bunched causing the difficulty removing.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

Event Description

It was reported the procedure was to treat an 85% stenosed, mildly calcified, and mildly tortuous lesion in the superficial femoral artery.The 10.0x19mm otw omnilink elite 35 balloon expandable stent system (bess) was advanced and the stent was deployed.Post stent deployment, it was observed that the balloon was bunched and was difficult to remove from the anatomy.Additionally, the bess became stuck in the guiding catheter; therefore, both devices had to be removed as a unit.The procedure was complete at this point, no additional devices were used.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned unit.The reported difficulty removing, bunched balloon and separation were 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 identified no other complaints.Based on the information provided, the reported difficulties and subsequent treatments appear to be due to case circumstances.It is likely that the balloon refolds, and profile became compromised post stent deployment due to interaction with the anatomy and/or stent during removal resulting in the balloon material becoming bunched causing the difficulty removing.Additionally, the separation likely occurred during the attempt to remove the bess against resistance.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D10, h3: device return status.H6: method code 4117 removed.

Event Description

It was reported the procedure was to treat an (b)(4) stenosed, mildly calcified, and mildly tortuous lesion in the superficial femoral artery.The 10.0x19mm otw omni elite 35 balloon expandable stent system (bess) was advanced and the stent was deployed.Post stent deployment, it was observed that the balloon was bunched and was difficult to remove from the anatomy.Additionally, the bess became stuck in the guiding catheter; therefore, both devices had to be removed as a unit.The procedure was complete at this point, no additional devices were used.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the account confirmed the hub of the 10.0x19mm otw omni elite 35 balloon expandable stent system (bess) separated on removal.Due to the bess being stuck in the guide catheter force was applied and the device was removed as one unit.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM.
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10396629
• MDR Text Key: 202722821
• Report Number: 2024168-2020-06709
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 11013-19
• Device Lot Number: 9061241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 09/04/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1