MAUDE Adverse Event Report: ABBOTT VASCULAR RX HERCULINK ELITE STENT SYSTEM; STENT, RENAL

Model Number 1011505-15

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.Sus event #mw5098900.

Event Description

User facility medwatch report received that states: the patient had left subclavian stenosis involving the ostium of the left vertebral artery.To induce retrograde vertebral flow throughout the case, the operating physician opted to place a moma device within the proximal subclavian artery.The distal balloon was removed and only the proximal occlusion was performed.After stabilizing the moma device, the proximal balloon was inflated in the very proximal left subclavian ensuring retrograde flow to the left vertebral.The left subclavian artery was successfully stented with a rx herculink elite 7 x 15 stent.Upon removal of the initial herculink stent balloon the balloon ruptured and a very small portion of the distal balloon may have been sheared off by moma device.However, no evidence of embolization was noted.The patient tolerated the procedure well without complications and was notified by the physician.Fda safety report id # (b)(4).

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.Additional information and/or return of the device may have further aided the analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing of the balloon material, materials, inflation technique, inflation over rated burst pressure, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported balloon rupture.In this case, it is possible that the balloon became damaged against the stent implant resulting in the reported balloon rupture; however, this could not be confirmed.Manipulation of the device during retraction likely caused the balloon separation in the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.The viatrac 14 balloon referenced in b5 is filed under a separate medwatch report number.D9, h3 - the device was initially reported as returning for analysis, but the device was not returned.

Event Description

Subsequent to the initially filed report, the device returned to abbott with the user facility medwatch report was a 7x20 mm viatrac 14 balloon dilatation catheter.Analysis of the device observed a balloon rupture.No additional information was provided.

• Brand Name: RX HERCULINK ELITE STENT SYSTEM
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11448806
• MDR Text Key: 238842993
• Report Number: 2024168-2021-01883
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08717648078378
• UDI-Public: 08717648078378
• Combination Product (y/n): N
• PMA/PMN Number: P110001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 1011505-15
• Device Catalogue Number: 1011505-15
• Device Lot Number: 0051461
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOMA EMBOLIC PROTECTION DEVICE
• Patient Outcome(s): Other
• Patient Age: 61 YR