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

Catalog Number S-55-150-120-P6

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

Patient Problems Headache (1880); Hypersensitivity/Allergic reaction (1907)

Event Date 12/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Therapy date has been estimated.There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.A review of the lot history record revealed no non-conformances.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacturing, design or labeling.The other supera and absolute pro devices referenced are being filed under separate medwatch mfr reference numbers.(b)(4).

Event Description

It was reported that the patient had an allergic reaction about 3 weeks after an absolute pro self-expanding stent system (sess) and two 5.5x115mm supera sesss were implanted on (b)(6) 2015.There is swelling and itching in various places on the body.Medications have been stopped, and benadryl was recommended by the physician.Severe headaches have recently started, and prednisone was prescribed.The symptoms started to return when prednisone course was terminated, and have been getting worse.No additional information was provided.

Manufacturer Narrative

(b)(4).It has been determined that this event is a duplicate event which was previously filed under mfr# 2024168-2016-00497.Correction: manufacturer site.

Manufacturer Narrative

(b)(4).

Event Description

Additional information indicates that the patient tested positive for allergy to supera stents.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5391738
• MDR Text Key: 36886012
• Report Number: 2024168-2016-00449
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 02400062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 100