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

Model Number 1012632-29

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2021

Event Type  malfunction  

Manufacturer Narrative

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.The first ominilink elite device referenced is filed a under separate medwatch report number.

Event Description

It was reported that this was a percutaneous intervention to treat the bilateral iliac arteries.When the 9.0x29 mm omnilink elite was being removed from the packaging hoop, the stent fell off of the stent delivery system on the back table; there was no patient involvement.Another 9.0x29 mm omnilink elite was prepared and inserted into the 6 french sheath, but was not able to come out of the sheath to use in the patient.The sheath had to be removed from the patient so the omnilink elite could be removed from the sheath.A new 6 french sheath of the same brand was used in the patient with two 8.0x29 omnilink elite stents without further incident.The physician felt that the first two omnilink elite stents were not crimped on the balloon delivery system properly.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

Visual, dimensional and functional inspections were performed on the returned device and the reported stent difficulty to advance and remove were confirmed.The reported stent dislodgement was unable to be confirmed as the stent was located between the markers as intended.There was no damage and no anomalies noted to the stent.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.Potential factors that may contribute to difficulty to advance and cause resistance between the omnilink elite and the introducer sheath (is) include, but are not limited to, manufacturing, incorrect size is used, sheath id (inner diameter), stent od (outer diameter), damage to the stent or damage to the is.The investigation was unable to determine a conclusive cause for the reported difficulty to advance and remove the stent delivery system (sds) through the is.The noted kinked shaft likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture.

• 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: 12136246
• MDR Text Key: 260510924
• Report Number: 2024168-2021-05831
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: 08717648178542
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

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 Model Number: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 1020441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 57