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

Catalog Number 42075100-080

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Renal Failure (2041); Respiratory Distress (2045); Thrombosis (2100); Weakness (2145)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 on (b)(6) 2019 a procedure was performed to treat a lesion in the external iliac artery.A 7.5 x 100 mm supera self expanding stent was deployed.The patient complained of discomfort before and during the procedure and post procedure reported feeling weak.The patient was transferred to another hospital where they underwent an open thrombectomy.Following the surgical procedure, the patient was transferred to the intensive care unit due to renal failure and respiratory complications.The patient was reported to be doing okay post procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (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.The reported patient effects of pain, renal failure and thrombosis are listed in the supera instructions for use as known patient effects associated with the use of the device.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the surgical procedure and hospitalization appear to be related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8691883
• MDR Text Key: 147750881
• Report Number: 2024168-2019-04623
• 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: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 42075100-080
• Device Lot Number: 8032661
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention