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

Catalog Number	1012581-26
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 difficulty to advance appears to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported device operates differently (failure to seal)/stent graft leak.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.(b)(4).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.
Event or Problem Description
It was reported that the patient presented with a free perforation with extravasation in the right vertebral artery.A 3.50x26mm rx graftmaster covered stent was attempted to be advanced but failed to cross due to anatomy.The lesion was then dilated with a 2.5x15mm unspecified balloon and the device was reinserted but still failed to cross due to anatomy.There was an exchange of wires and a wiggle wire was used.The lesion was then dilated with a 3.0mm unspecified balloon and the device was able to cross successfully.The covered stent was deployed at 14 atmospheres, but the perforation was not sealed as there was a small region of extravasation of contrast noted.The stent was then post-dilated with a 4.0x15mm unspecified balloon with multiple inflations up to 14 atmospheres.Repeat angiography showed the stent widely patent and no extravasation.There were no reported adverse patient sequelae.No additional information has been provided.

• 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: 9173168
• Report Number: 2024168-2019-12468
• Device Sequence Number: 16776215
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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: 12/31/2019
• Device Catalogue Number: 1012581-26
• Device Lot Number: 8011741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/09/2019
• 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: WIGGLE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR