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

Catalog Number	1012581-26
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001 -permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 3.5x19 mm graftmaster stent referenced is being filed under a separate medwatch report #.
Event or Problem Description
It was reported that there was a large vessel perforation in the distal left anterior descending coronary artery which occurred after atherectomy was performed.The doctor knew he would need several graftmasters to treat the perforation.The graftmasters did not worsen the perforation, but it was difficult to locate where the perforation was leaking from.The perforation was not completely sealed by the four graftmasters, so a fifth stent (size 3.5x26) was inserted to be placed proximal to the first four stents, but it was not able to reach the vessel.The undeployed 3.5x26 graftmaster was removed with difficulty as a unit with the guide wire and guiding catheter.The undeployed graftmaster was noted to have frayed stent struts on the distal end.Another graftmaster was inserted and was successfully deployed.The perforation was sealed with the fifth graftmaster.There were no adverse events related to the graftmaster.No additional information was provided.
Event or Problem Description
It was reported that there was a large vessel perforation in the distal left anterior descending coronary artery which occurred after atherectomy was performed.The doctor knew he would need several graftmasters to treat the perforation.The graftmasters did not worsen the perforation, but it was difficult to locate where the perforation was leaking from.The perforation was not completely sealed by the four graftmasters, so a fifth stent was inserted to be placed proximal to the first four stents, but it was not able to reach the vessel.The undeployed graftmaster was removed with difficulty as a unit with the guide wire and guiding catheter.The undeployed graftmaster was noted to have frayed stent struts on the distal end.Another graftmaster was inserted and was successfully deployed.The perforation was sealed with the 5th graftmaster.There were no adverse events related to the graftmaster.No additional information was provided.
Additional Manufacturer Narrative
A visual, functional and dimensional inspection was performed on the returned device.The reported material deformation was confirmed.The reported failure to advance and difficult to remove could not be tested as it was based on operational circumstances.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• 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: 9088502
• Report Number: 2024168-2019-11927
• Device Sequence Number: 19439294
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/15/2019

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: 06/30/2020
• Device Catalogue Number: 1012581-26
• Device Lot Number: 8072741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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: 3.5X19 MM GRAFTMASTER STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 93