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

Catalog Number 1012631-39

Device Problems Material Rupture (1546); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be related to case circumstances.It is likely that the balloon rupture was the result of interaction with the heavily calcified lesion resulting in partial deployment of the stent.The additional therapy/non-surgical treatment was also due to circumstances of the procedure as an unspecified balloon catheter was used to post-dilate the stent to achieve wall apposition.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 procedure was performed to treat a 60% stenosed, mildly tortuous, and heavily calcified de novo lesion in the common iliac artery.An 8x39mm otw omni elite stent delivery system (sds) was advanced; however, the balloon ruptured during the first inflation between 6 to 8 atmospheres during deployment.An unspecified balloon catheter was used to post-dilate the stent to achieve wall apposition.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: OMNILINK ELITE
• 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: 9193432
• MDR Text Key: 162792358
• Report Number: 2024168-2019-12618
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178511
• UDI-Public: 08717648178511
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/15/2019

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: 07/31/2021
• Device Catalogue Number: 1012631-39
• Device Lot Number: 8022241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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
• Patient Outcome(s): Required Intervention