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

Model Number	1012582-26
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The 4.0x16mm graftmaster stent referenced is filed under a separate medwatch report number.
Event or Problem 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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9663132
• Report Number: 2024168-2020-01155
• Device Sequence Number: 2784275
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1012582-26
• Device Catalogue Number: 1012582-26
• Device Lot Number: 9071641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1