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

Catalog Number	1012582-26
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional grafmtaster devices referenced in b5 are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that during a procedure to treat a lesion in the left anterior descending coronary artery with moderate calcification and moderate tortuosity, the patient presented with a free perforation with extravasation.A 4.00 x 26 mm graftmaster covered stent delivery system (sds) was deployed; however, the perforation was not completely sealed.A 3.50 x 16 mm graftmaster stent was advanced but could not cross the lesion due to resistance with a 6f unspecified sheath.Two further graftmaster stents (3.50 x 16 mm and a 2.80 x 16 mm) were deployed but the perforation still did not fully seal.Ultimately a 2.80 x 16 mm graftmaster covered stent was successfully deployed; however extravasation was still noted.The patient left theater on an extracorporeal membrane oxygenation [ecmo] system.Anticoagulation was reversed and the dissection was noted to have self sealed.The patient was extubated and was initially reported to be stable.The patient declined further medical intervention and reportedly expired from heart failure 4 days post procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.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 was unable to determine a conclusive cause for the reported failure to seal; however, the subsequent treatment appears 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.

• 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: 8884026
• Report Number: 2024168-2019-10761
• Device Sequence Number: 2447679
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/04/2019

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: 05/31/2020
• Device Catalogue Number: 1012582-26
• Device Lot Number: 8060541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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: 6F GUIDING CATHETER; 6F GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR