MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1235300-28

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.It should be noted that the absorb gt1 instructions for use states: an unexpanded scaffold may be retracted into the guiding catheter one time only.An unexpanded scaffold should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the scaffold may be damaged or dislodged during retraction back into the guiding catheter.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery with a 90% angle from the left main to the lad.Pre-dilatation was performed with a 3.0 x 20 mm non-compliant balloon.The 3.0 x 28 mm absorb gt1 delivery catheter was advanced, but it couldn't be advanced all the way to the lesion.The delivery catheter was removed and backloaded into a 6f guideliner and advanced it again, but it still would not go.Resistance was met with the anatomy and the guideliner.An attempt was made to pull the delivery catheter back into the guideliner, but it wouldn't go in all the way.The devices were removed together from the patient.Upon examination of the device, the scaffold was damaged from getting caught on the end of the guideliner.A xience stent was implanted with a good patient outcome.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6108136
• MDR Text Key: 60282630
• Report Number: 2024168-2016-08019
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213069
• UDI-Public: (01)08717648213069
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150023
• 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
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1235300-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: OTHER: 6F GUIDELINER