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

Catalog Number 11006-29

Device Problems Difficult to Insert (1316); Stretched (1601); Difficult to Advance (2920)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned omnilink elite.The difficulty to insert and difficulty to advance was unable to be confirmed due to the condition of the returned unit.The balloon, stent and shaft were damaged.The damage likely occurred during the attempt to advance into the sheath against resistance.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 complaints reported from this lot.The investigation determine that the reported difficulties were due to operational context.Based on measurements taken of the returned non-abbott introducer sheath of 0.084-inches on the distal end, and 0.087-inches on the proximal end, the difficulty inserting, and advancing was due to using an undersized sheath.The recommended sheath inner diameter for this device as specified on the product label is 0.087 inches (2.20 mm).There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that an attempt to advance a 10x29mm otw omni elite balloon-expandable stent system (bess) through a 6f sheath was made; however, there was difficulty inserting the bess into the sheath and resistance during advancement.The intervention was canceled because the patient was no longer cooperative and the sheath could not be changed.There were no adverse patient effects and no clinically significant delay in the procedure.The returned device analysis identified that the outer member and the inner member were wrinkled and stretched sporadically proximal to the balloon proximal seal for a length of 3.5 cm.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12417863
• MDR Text Key: 270121794
• Report Number: 2024168-2021-07846
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

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 Expiration Date: 02/29/2024
• Device Catalogue Number: 11006-29
• Device Lot Number: 0090141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1