MAUDE Adverse Event Report: AV-TEMECULA-CT RX HERCULINK ELITE STENT SYSTEM

Catalog Number	1011499-18
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, 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 design, manufacture or labeling of the device.
Event or Problem Description
It was reported that a 6.0 x 18 mm herculink elite stent was implanted in the superior mesenteric artery.Three to four days after stent implantation the patient's hands started itching and within two weeks a rash developed over the upper body and arms, which has now spread to the head.The patient's plavix was changed as well as the blood pressure medication.The patient was put on prednisone to treat the rash; however, while the rash calmed down it did not go away.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the surgical procedure, treatment with medication and hospitalization appears to be related to the circumstances of the patient effect (hypersensitivity).There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
Subsequent to the initial medwatch report the following new information was received: the patient confirmed that she is allergic to chromium and manganese.The stent was surgically explanted /removed from the patient on (b)(6) 2018.The hot burning rash is gone.The itching has decreased to more of a topical itch and although annoying, it is manageable.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Common Device Name: STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7254192
• Report Number: 2024168-2018-00941
• Device Sequence Number: 1035758
• Product Code: NIN
• UDI-Device Identifier: 08717648078200
• UDI-Public: 08717648078200
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P110001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1011499-18
• Device Lot Number: 6120861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 44