MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	85414
Health Effect - Clinical Codes	Occlusion (1984); Blood Loss (2597)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Hospital reported that the patient was having a transcatheter aortic valve replacement (tavr) procedure in the cath lab.Due to a high stick, there was bleeding in the left femoral artery and in order to repair, the physician attempted to place 2 stents in the left femoral artery (lfa)/iliac.One stent was deployed and the other slipped off of the balloon undeployed.Associated mdr: (b)(4).
Additional Manufacturer Narrative
Analysis: a review of the complaint details indicate that only one of two icast covered stents was successfully deployed as one stent was somehow dislodged off the balloon in the patient¿s artery.As the details provided do not explain the circumstances surround the stent migration off the balloon in the un-deployed state, the cause is difficult to determine.There is a possibility that during placement of the stent the distal end of the introducer sheath made contact with the proximal end of the crimped stent pushing the stent off the balloon.There is also a possibility that the stent was dislodged off the balloon when the stent was positioned inside the previously deployed icast covered stent.There was a list of questions sent to the institution to better understand the circumstances surrounding the stent dislodgement, however, none of our inquiries were answered.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of icast covered stent systems is tested to.This inspection requires that the catheter lot must pass the following: ¿ ability of the stent and delivery system to be passed through the labeled introducer sheath (6fr).Ability to deploy the stent at nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.Ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Stent retention testing.Stent must have retention = 5.5n for 6fr introducer sheath/guide.In addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification.Stent securement testing.Proximal balloon weld tensile testing as detailed above.Distal tip tensile testing.Catheter leak check.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Conclusion: based on the review of the complaint details and the device history records review atrium medical cannot conclude that there was an issue with the product in question.H3 other text : not returned.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8994686
• Report Number: 3011175548-2019-00957
• Device Sequence Number: 3324021
• Product Code: JCT
• UDI-Device Identifier: 00650862854152
• UDI-Public: 00650862854152
• Combination Product (Y/N): N
• Initial Reporter State: MI
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: 85414
• Device Catalogue Number: 85415
• Device Lot Number: 433218
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT PROVIDED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR