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

Catalog Number 11005-59

Device Problems Inflation Problem (1310); Difficult or Delayed Activation (2577); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.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 incident(s) there is no indication of a lot specific product quality issue.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the inner diameter of the terumo 6f introducer sheath was smaller than the labeled recommended minimum id and may have contributed to the reported resistance during the initial advancement.The product label for this lot lists a recommended minimum introducer sheath of 6f with an id of 0.085 inches (2.15mm).It may be possible that the terumo 6fr sheath was not the appropriate id; however, without having the omnilink elite and terumo sheath returned to examine, the exact inner diameter of the sheath is unknown and therefore could not be confirmed.Additionally, it may be possible that the stent became compromised after the first failed attempt to advance against resistance resulting in further difficulties (resistance) when advancing through the 7f sheath.Anatomical conditions which were reported as moderately tortuous and moderately calcified may have prevented the stent from fully expanding in the middle causing the irregular inflation and deployment issue; however, this could not be confirmed.The reported treatment appears to be related to the operational context of the procedure as post dilatation was then performed on the stent to fully deploy the stent in the middle section.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 the cross over procedure was performed to treat a moderately tortuous and moderately calcified lesion in the iliac artery.A 6fr sheath was advanced and an attempt to advance a 9.0x59mm otw omni elite 35 balloon expandable stent system (bess) was made but resistance with the sheath was felt.The sheath was switched to a 7fr sheath.The bess was advanced; however, again resistance was felt with the sheath but the bess reached the target lesion.During deployment the edges of the stent expanded as they should, but it was noted that the middle part of the omnilink did not expand as easily.Post dilatation was performed to ensure optimal wall apposition and the procedure was successfully completed with optimal outflow.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.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 incident(s) there is no indication of a lot specific product quality issue.The investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that the inner diameter of the non-abbott 6f sheath was smaller than the labeled recommended minimum id and may have contributed to the reported resistance during the initial advancement.The product label for this lot lists a recommended minimum introducer sheath of 6f with an id of 0.085 inches (2.15mm).It may be possible that the non-abbott sheath was not the appropriate id; however, without having the omnilink elite and sheath returned to examine, the exact inner diameter of the sheath is unknown and therefore could not be confirmed.Additionally, it may be possible that the stent became compromised after the first failed attempt to advance against resistance resulting in further difficulties (resistance) when advancing through the 7f sheath.Anatomical conditions which were reported as moderately tortuous and moderately calcified may have prevented the stent from fully expanding in the middle causing the irregular inflation and deployment issue; however, this could not be confirmed.The reported treatment appears to be related to the operational context of the procedure as post dilatation was then performed on the stent to fully deploy the stent in the middle section.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H10: addtl mfg narrative updated.

• 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: 10260835
• MDR Text Key: 198506731
• Report Number: 2024168-2020-05679
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 11005-59
• Device Lot Number: 7053141
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6FR; SHEATH:7 FR TERUMO
• Patient Outcome(s): Required Intervention