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

Model Number	1012630-19
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the 7x 15 mm, circumferential bifurcation of the pulmonary artery with 75% stenosis.Pre-dilatation was not performed and the 7x19 mm omnilink elite stent was inflated once to 11 atmospheres (atm) and then up to 14 atm.The balloon ruptured at 14 atm for 30 seconds; however, the stent was deployed at the intended location.Next, the 10x19 mm omnilink elite stent was inflated to 11 atm and then up to 14 atm to deploy the stent and complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, it was noted that the vessel is 7x15 mm.
Additional Manufacturer Narrative
H6 device code 2017 clarifier: failure to follow steps / instructions.A visual inspection was performed on the returned device.The reported material rupture was 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 incidents.It was reported that the procedure was to treat the 7 x 15 mm, circumferential bifurcation of the pulmonary artery with 75% stenosis.It should be noted that the omnilink elite instructions for use (ifu), states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of = 5.0 mm and = 11.0 mm, and lesion lengths up to 50 mm.It is unknown if the ifu deviation directly caused or contributed to the reported event.In addition, it was reported that pre-dilatation was not performed.It should be noted that the omnilink elite instructions for use, states: pre-dilate the lesion with an appropriate size balloon dilatation catheter to closely match the lumen diameter proximal and distal to the lesion.It is possible the ifu deviation directly caused or contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported material rupture; however, factors that may contribute to material ruptures include, but are not limited to, damaged material, inflation technique, interactions with other devices, lesion calcification and tortuosity or insufficient preparation prior to use.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue did not contribute to the reported material rupture.In this case, it is possible that interaction with the 75% stenosed lesion during inflation/deployment of the stent may have contributed to the reported material rupture, as it was reported that pre-dilatation of the lesion was not performed prior to use; however, this cannot be confirmed.It should be noted that the omnilink elite instructions for use specifies to pre-dilate the lesion with an appropriate size balloon dilatation catheter to closely match the lumen diameter proximal and distal to the lesion.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: 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: 15591906
• Report Number: 2024168-2022-10594
• Device Sequence Number: 2278230
• Product Code: NIO
• UDI-Device Identifier: 08717648178450
• UDI-Public: 08717648178450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012630-19
• Device Catalogue Number: 1012630-19
• Device Lot Number: 9120941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7F FLEXOR ANSEL GUDING SHEATH 55CM; AMPLATZ SUPER STIFF GW 0.035 260CM×2
• Patient Sex: Unknown