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

Catalog Number UNK SUPERA

Device Problems Difficult or Delayed Activation (2577); Defective Device (2588)

Patient Problem Death (1802)

Event Date 05/21/2020

Event Type  Death  

Manufacturer Narrative

The stent remains in the patient.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 a long superficial femoral artery (sfa) recanalization of the sfa and profunda arteries.There was reportedly not very much calcification.The vessel diameter was 5-6 mm and the vessel was prepared with a 5.5 mm balloon at rated burst pressure for 3 minutes.During deployment of the supera self expanding stent (ses), the push over the sheath while trying to pack the stent caused the delivery system to fall into the already deployed portion of the stent (invagination), causing a focal 3 layer stent position, which resulted in significant narrowing.The patient expired the next day and according to the physician it was related to the difficult deployment of the supera ses.No additional information was provided.

Manufacturer Narrative

Udi# 42055200-120 / 0021961 - udi#(b)(4).42055100-080 / 9091861 - udi#(b)(4).42055100-080 / 8112661 - udi#(b)(4).The device was not returned for analysis.A review of the lot history records identified no manufacturing nonconformities issued to the reported lots that would have contributed to this event.Additionally, a review of the complaint history identified no other similar complaints from the reported lots.An abbott vascular medical affairs expert reviewed the case details and conclude the following: the patient had critical limb ischemia and needed a patent vessel because the already mentioned severe arterial problems plus her other co-morbidities are all contributing factors to the patient¿s death.The supera may have indirectly contributed due to the difficulty in the deployment which have caused delay in the procedure and have compromised the patient.The investigation determined that the reported deployment difficulty was likely the result of deployment technique.Based on the reported information, the reported deployment issue likely occurred due to forward pushing of the delivery system while trying to pack the stent causing the delivery system to fall into the already deployed portion of the stent (invagination of the stent), causing a focal three-layer stent conformation with extremely significant narrowing.The reported patient effect of death is listed in the supera instructions for use as a known potential adverse effect of peripheral percutaneous intervention.In this case, a conclusive cause for the patient death, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Additional information: three supera stents were implanted during this procedure; however, it is not known which one had the deployment issue.5.5x200 supera (42055200-120 lot 0021961); 5.5x100 supera (42055100-080 lot 9091861); 5.5x100 supera (42055100-080 lot 8112661).

Manufacturer Narrative

There were three supera stents were used during this procedure; however, it is not known which had the deployment issue.The manufacturing date and expiration dates for all three stents are as follows: 5.5x200 supera (42055200-120 lot 0021961).Manufacturing date: 2020-02-19.Expiration date: 2022-01-31.5.5x100 supera (42055100-080 lot 9091861).Manufacturing date: 2019-09-18.Expiration date: 2021-08-31.5.5x100 supera (42055100-080 lot 8112661).Manufacturing date: 2018-11-26.Expiration date: 2020-10-31.

• Brand Name: SUPERA PERIPHERAL 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: 10174935
• MDR Text Key: 195801657
• Report Number: 2024168-2020-05185
• Device Sequence Number: 1
• Product Code: NIP
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/01/2020

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 Catalogue Number: UNK SUPERA
• Device Lot Number: UNKNOWN SUPERA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 08/11/2020
• Supplement Dates FDA Received: 08/11/2020; 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPERA SES X2.
• Patient Outcome(s): Death
• Patient Age: 83 YR