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

Catalog Number 1234300-18

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Angina (1710); Ischemia (1942); Thrombosis (2100); Heart Failure (2206)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Internal file number - (b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A 3.5x15mm unspecified nc balloon catheter was advanced but hardly crossed the lesion and was inflated; however, recanalization was not achieved.Balloon dilatation was repeated several times but the result was the same.There was a clinically significant delay due to the event.Medication therapy was given to the patient and the patient was kept under observation in the hospital as ischemia had occurred and heart failure developed.The patient was released on (b)(6) 2016.Reportedly, the patient was compliant with their dual anti-platelet therapy post index procedure involving clopidogrel.Post thrombosis, the patient was started on triple therapy (aspirin, aggrastat, plavix) and also clexane.The patient has no prior history of heart failure.No additional information was provided (b)(4).The absorb gt1 3.5 x 28 mm referenced is being filed under a separate manufacturer report number.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina, thrombosis and ischemia, as listed in the absorb gt1 instructions for use (ifu), are known adverse events associated with the use of a coronary scaffold in native coronary arteries.It should be noted that the absorb gt1, instructions for use (ifu) states: it is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon or lesion with greater than 40 percent residual stenosis after pre-dilatation by visual estimation.Additionally, it should be noted that the ifu states: the absorb gt1 bvs is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart disease due to de novo native coronary artery lesions.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.

Event Description

It was reported that the patient was asymptomatic prior to the index procedure on (b)(6) 2016 which was to treat a lesion located in the mid left anterior descending (lad) with a length of 25 mm.Vessel sizing was done with quantitative coronary angiography and the vessel was determined to be greater than 2.5mm.Predilatation was done with a 3.0x20mm non-abbott balloon catheter.Residual stenosis was about 50-55%.A 3.5x28mm absorb gt1 was successfully implanted; however, the scaffold had no impact on patency.Residual stenosis was almost the same.Post-dilatation was performed with a 3.5x15mm nc non-abbott balloon at 18 atmospheres (atm).Result was not satisfactory and post dilatation was repeated some more times; however, the final angiographic residual stenosis was greater than 10%.No imaging was done to confirm the scaffold was fully apposed to the vessel wall.A dissection occured around the distal part of the scaffold.A second absorb (3.0x18) was implanted on the dissection side with overlapping.Post-dilatation was performed with a 3.0x15 unspecified nc balloon catheter for the second absorb segment and a 3.5x15 unspecified nc balloon catheter was used for the overlapped segment.The result was considered optimal for the patient and case finished.The patient returned to the clinic on (b)(6) 2016 with severe chest pain.Both absorb gt1 scaffolds were observed to be totally occluded due to thrombosis.

Manufacturer Narrative

(b)(4).Correction: the received by mfr date on the initial medwatch report was filed incorrectly as 12/12/2016, but should have been 12/09/2016.

• 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: 6195303
• MDR Text Key: 63007630
• Report Number: 2024168-2016-09113
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212802
• UDI-Public: (01)08717648212802(17)170509(10)5111261
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2017
• Device Catalogue Number: 1234300-18
• Device Lot Number: 5111261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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: SCAFFOLD: ABSORB GT1 3.5 X 28 MM
• Patient Outcome(s): Hospitalization; Required Intervention