MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number SE-06-100-080-6F

Device Problem Break (1069)

Patient Problems Thrombosis (2100); Claudication (2550)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The udi is unknown because the part and lot numbers were not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation was unable to determine the cause for the reported stent fracture and subsequent patient effects.The reported patient effects of thrombosis and claudication are listed as potential patient effects associated with the use of the device and are listed in the supera instruction for use.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 at the leipzig interventional course (linc) 2019 conference in (b)(6) an event that took place in (b)(6) with an unspecified supera peripheral stent system.The presentation was titled: "endovascular treatment of popliteal thrombosis secondary to supera stent fracture" the procedure occurred around (b)(6) 2018, where right popliteal thrombosis was noted and balloon angioplasty was then performed.An unspecified 6.5mm supera was then implanted.Six months later, severe right limb claudication and in-stent thrombosis was noted.The stent implant became fractured.Endovascular treatment was performed by using intra-stent angioplasty with a second 5.5mm supera stent to cover the fracture of the previous stent.The patient was discharged the next day with medication.Three month follow-up showed the patient remained asymptomatic with preserved distal pulses.The treatment was deemed a feasible and safe technique producing good results.The patient is in good condition.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Attachment article titled: endovascular treatment of popliteal artery occlusion caused by ruptured supera interwoven nitinol stent.Correction: patient age updated from 60 to 51 years.

Event Description

Subsequent to the initially filed mdr report, the article titled: "endovascular treatment of popliteal artery occlusion caused by ruptured supera interwoven nitinol stent" was received.Please see attached article for additional details.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8337625
• MDR Text Key: 136109720
• Report Number: 2024168-2019-01093
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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 Catalogue Number: SE-06-100-080-6F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 72