MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER; CORONARY STENT DELIVERY SYSTEM

Model Number 1012582-16

Device Problems Device Damaged by Another Device (2915); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

The stent remains implanted.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal of the filter interaction with the retrieval catheter resulted in the reported migration and device damaged by another device (dislodged the deployed stent with the filter wire retrieval device).There is no indication of a product quality issue with respect to manufacture, design or labeling.The 4.0x26mm graftmaster stent system referenced is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a lesion in the saphenous vein graft.During use of an unspecified device, a perforation occurred.The 4.0 x 26 mm graftmaster stent delivery system was removed from the packaging for device preparation; however, the stent dislodged from the delivery system.The device was not used and there was no patient involvement.The procedure continued.An unspecified embolic protection filter was placed.The 4.0 x 16 mm graftmaster stent was then advanced into the patient anatomy.The stent was deployed without issue, sealing the perforation.However, during removal of the filter, the retrieval catheter interacted with the implanted graftmaster stent, moving the stent out of position, so that it no longer fully covered the perforation.An additional graftmaster stent, a 4.5 x 26 mm, was then deployed, sealing the perforation and anchoring the 4.0 x 16 mm graftmaster stent.The perforation was sealed and there was no adverse patient effect.There was no clinically significant delay.No additional information was provided.

• Brand Name: GRAFTMASTER
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9663098
• MDR Text Key: 177590741
• Report Number: 2024168-2020-01156
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176449
• UDI-Public: 08717648176449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 1012582-16
• Device Catalogue Number: 1012582-16
• Device Lot Number: 8062241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2018
• 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: 71 YR
• Patient Weight: 97