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

Catalog Number 1234300-23

Device Problems Difficult To Position (1467); Physical Resistance (2578)

Patient Problems Ischemia (1942); Prolapse (2475)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported resistance during advancement and patient effects appear to be related to circumstances of the procedure.The reported patient effect of ischemia, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the patient presented with chronic stable angina.The procedure on (b)(6) 2017 was to treat a lesion located in the distal left anterior descending (lad) artery with heavy calcification and 90% stenosis.Vessel sizing was performed and the diameter was determined to be greater than 2.5mm.Predilatation was performed with a 2.5x15 semi-compliant balloon and then with a 3.0x20 balloon with residual stenosis 70%.A 3.0x23mm absorb gt1 was advanced to the distal part of the lesion with some difficulty in deliverability due to heavy calcification causing a plaque shift within the target lesion which caused timi 1 flow.Another 3.0x23mm absorb gt1 was advanced; however, it failed to cross the proximal part of the previously implanted absorb gt1 to overlap proximally.The procedure was successfully completed with an unspecified drug eluting stent which treated both the proximal end of the lesion as well as the plaque shift.There was a good final patient outcome.There was no reported adverse patient sequelae or clinically significant delay in procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to filing the initial mdr, the following additional information was received: the patient's ischemia and plaque shift were also treated with abciximab with a final timi 3 flow.The procedure was prolonged due to the treatment.

• 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: 6417741
• MDR Text Key: 70372309
• Report Number: 2024168-2017-02319
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212819
• UDI-Public: (01)08717648212819(17)170911(10)6031661
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2017
• Device Catalogue Number: 1234300-23
• Device Lot Number: 6031661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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