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

Catalog Number 1012818-19

Device Problems Unsealed Device Packaging (1444); Failure to Advance (2524)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4)-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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the heavily calcified and moderately tortuous left anterior descending (lad) artery.A perforation occurred and the 3.5 x 19 mm graftmaster stent was advanced; however, the device was unable to cross due to the patient anatomy.After several attempts to cross, the decision was made to remove the device and a second graftmaster was used.The second graftmaster was able to cross and was implanted without issue.The procedure was performed successfully.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the device was not used because the outer chipboard box was opened and it was noted that the inner sterile pouch was unsealed.There was no patient involvement.No additional information was provided.

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.A visual and dimensional inspection was performed on the returned device.The reported unsealed device packaging could not be tested or confirmed as the inner pouch was not returned.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 other incidents.The investigation was unable to determine a conclusive cause for the reported unsealed device packaging.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.An adverse event did not occur.Patient code 2199 - removed.Device code 2524 - removed.

• Brand Name: GRAFTMASTER
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9083984
• MDR Text Key: 161339935
• Report Number: 2024168-2019-11887
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 1012818-19
• Device Lot Number: 9012841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention