MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012581-19

Device Problems Inflation Problem (1310); Leak/Splash (1354); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The other 3.5x19mm graftmaster is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat a left anterior descending artery.A perforation was caused by another device and 3 graftmaster covered stents were used to treat the perforation.A 3.5 x 19 mm graftmaster stent was advanced to be deployed; however, when inflated, the balloon would not fully inflate and the stent dislodged.The dislodged stent was then crushed against the vessel wall with a balloon catheter.Outside the anatomy, it was noted that there was a pin hole in the shaft near the hub.The perforation was quite large so two stents were required to seal the perforation.First, a 3.5 x 16 mm graftmaster stent was deployed at 20 atmospheres.Then a second 3.5 x 19 mm graftmaster stent was deployed at 22 atmospheres; however, there was also difficulty inflating the balloon.The stent implant was deployed to completely seal the perforation.Outside the anatomy, it was noted that there was a pin hole in the shaft near the hub.The patient was in stable condition.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual and functional inspection was performed on the returned device.The reported inflation issue, shaft leak and stent dislodgement were confirmed.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 inflation issue, shaft leak, stent dislodgement and device embedded in vessel or plaque 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.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7080670
• MDR Text Key: 93682186
• Report Number: 2024168-2017-09370
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1012581-19
• Device Lot Number: 6121441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 88