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

Catalog Number	1012581-26
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.G9: 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 other graftmaster device referenced in b5 and d11 is being filed under a separate medwatch report number.H3 other text : the stent remains in patient.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the radial artery.A 2.8 x 26 mm and a 3.5 x 26 mm graftmaster covered stent were implanted; however, both failed to seal the perforation.Therefore, post-dilatation was performed with a 3.5 x 20 mm non-abbott balloon catheter as medical intervention to seal it.There was no adverse patient sequela reported.No additional information was provided.
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 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 identified no similar incidents from this lot.The investigation determined the reported patient-device incompatibility/device operates differently (failure to seal)/stent graft leak appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat a perforation in the radial artery.A 2.8 x 26 mm and a 3.5 x 26 mm graftmaster covered stent were implanted; however, both failed to seal the perforation.Therefore, post-dilatation was performed with a 3.5 x 20 mm non-abbott balloon catheter as medical intervention to seal it.There was no adverse patient sequela reported.No additional information was 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: 8890803
• Report Number: 2024168-2019-10825
• Device Sequence Number: 3295049
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 09/27/2019

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: 08/31/2019
• Device Catalogue Number: 1012581-26
• Device Lot Number: 7092041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/27/2019
• 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: 2.8 X 26 MM GRAFTMASTER; 2.8 X 26 MM GRAFTMASTER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 47