MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number S-45-080-120-P6

Device Problems Material Separation (1562); Activation Failure (3270)

Patient Problem Ischemia (1942)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The customer reported the device was retained by the hospital and will not be returned.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a mildly calcified proximal popliteal artery.It was a percutaneous intervention procedure without atherectomy.The 4.5x80mm supera peripheral stent delivery system was advanced without any resistance noted.During deployment, it was believed that the stent was fully released but when the catheter was pulled back, the stent came back with it.It was confirmed via fluoroscopy that the stent was no longer in place and it was moved to the common femoral artery.Outside of the patient it was noted that the tip was separated.A groin cut down was done to retrieve the stent and separated tip.Post the groin cut down, the patient had a limited flow in the anterior tibial artery.The physician was not sure if the limited flow was due to the time of getting the stent and tip out or if plaque had caused it.The physician then opted for a full femoral popliteal bypass to treat the unstented proximal popliteal.The flow from the bypass restored the flow in the anterior tibial artery.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 similar incidents.The reported patient effect of ischemia is listed in the supera instruction for use as a known potential adverse effect associated with peripheral percutaneous intervention.Based on the information provided, a conclusive cause for the reported difficulties could not be determined.The additional event of ischemia is related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Attachment: user facility medwatch report # (b)(4).

Event Description

It was reported that the procedure was performed to treat a mildly calcified proximal popliteal artery.It was a percutaneous intervention procedure without atherectomy.The 4.5x80mm supera peripheral stent delivery system was advanced without any resistance noted.During deployment, it was believed that the stent was fully released but when the catheter was pulled back, the stent came back with it.It was confirmed via fluoroscopy that the stent was no longer in place and it was moved to the common femoral artery.Outside of the patient it was noted that the tip was separated.A groin cut down was done to retrieve the stent and separated tip.Post the groin cut down, the patient had a limited flow in the anterior tibial artery.The physician was not sure if the limited flow was due to the time of getting the stent and tip out or if plaque had caused it.The physician then opted for a full femoral popliteal bypass to treat the unstented proximal popliteal.The flow from the bypass restored the flow in the anterior tibial artery.There was no adverse patient sequela reported.No additional information was provided.Subsequent to filing the initial medwatch report, a user facility medwatch report was received: medwatch case details: [physician was implanting a supera stent percutaneously when they felt it release and the cone tip was released into the previous stent and he was unable to dislodge it during angiograms.Physician decided to do a right femoral cutdown and exploration with removal of the stent.All pieces of the stent were removed.].

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8941383
• MDR Text Key: 155993821
• Report Number: 2024168-2019-11282
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648225963
• UDI-Public: 08717648225963
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2020

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: 07/31/2020
• Device Model Number: S-45-080-120-P6
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 8081661
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 10/22/2019; 07/20/2020
• Supplement Dates FDA Received: 11/11/2019; 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F COOK FLEXOR 30CM
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 56 YR