MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85420

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that the balloon stent ruptured when the doctor implanted it on the left iliac.Balloon stent inspected by surgeon by inflating and making sure everything is intact.Surgeon informed staff and charge nurse that the balloon stent is intact.The surgeon identified occlusion at left lower artery and at the anterior tibial artery.The intended procedure was an aortogram with iliac artery stent insertion.

Event Description

Additional information received: the left balloon had popped and thus to continue reinflation of the balloon a 10 x 40 mm mustang balloon was inserted.This was deployed under radiologic supervision.Once they were deployed in kissing fashion, the balloons were taken down.Repeat angiogram showed an excellent angiographic result with patent infrarenal aorta, patent common iliac, patent external iliacs and patent hypogastrics bilaterally.

Manufacturer Narrative

Additional information: b5 and d10.

Manufacturer Narrative

The complaint details state that an icast 10mmx38mmx80cm balloon ruptured when implanted in the left iliac.The intended procedure was an aortogram with iliac artery stent insertion.Based on follow-up questions asked of the complainant, it was noted that the balloon would not inflate completely.A 10mmx40mm mustang balloon was used to continue inflation under radiologic supervision.Balloons were deployed in a kissing fashion.It is unknown what deployment pressure was able to be achieved.It is also unknown if the lesion was calcific or had been predilated.The surgeon did note occlusion at the left lower artery and at the anterior tibial artery may have influenced the outcome of the event.No images of the procedure have been provided.After many attempts to obtain the product, it has not been returned for evaluation.Additionally, no lot number for the device was provided; thus a device history review could be performed.Therefore, the complaint cannot be confirmed.The medical review of the complaint details, including that fact that this event involved placement of an icast balloon in a totally occluded iliac artery, highlights that factors likely to have attributed to this event include but are not limited to, iliac artery extensive calcification and plaque formation, vessel tortuosity, balloon became bunched up at the end of the introducer sheath and made contact with calcific plaque, and excessive balloon manipulation during delivery.It is also possible that because the stents were deployed in a kissing fashion, the balloon made contact with the other stent and became damaged.Therefore, most likely root cause is operational context.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.While a number of complaints involving a balloon burst were identified, there have been no adverse trends noted.None of the complaints were able to be attributed to a manufacturing or device defect and the cases involved deployment in conjunction with another device or deployment in or around a calcified lesion.These circumstances may have contributed to the balloon damage observed, similar to this event.The ncr/capa review did identify one ongoing capa related to balloon pinhole defects from the crimping process.It is unknown if this complaint is related; however, given the device use in a kissing stent procedure and use in a totally occluded iliac artery, the most likely cause is operational context.The complaint has not been confirmed to have been directly related to the product and there is no indication of any nonconformance, nor a design, labeling, or manufacturing problem, based on the details available.The complaint is adequately covered in the risk management file, is operating within the approved risk profile, and no adverse trends have been detected.Based on the findings of this investigation, no further escalation or corrective actions are needed.H3 other text : device not returned.

Event Description

N/a.

• Brand Name: I-CAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11781084
• MDR Text Key: 250185963
• Report Number: 3011175548-2021-00489
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854206
• UDI-Public: 00650862854206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85420
• Device Catalogue Number: 85420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10 X 40 MM MUSTANG BALLOON.
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 55 KG