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

Catalog Number 1234350-28

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Intimal Dissection (1333); Angina (1710); Ischemia (1942); Thrombosis (2100); Heart Failure (2206)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

(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.Concomitant product therapy date (b)(6) 2016: balloon catheter: nc sprinter 3.5x15, concomitant product therapy date: (b)(6) 2016 scaffold: absorb gt1 3.0x18.(b)(4).The absorb gt1 3.0 x 18 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.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of dissection, 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 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% residual stenosis after pre-dilatation by visual estimation.The investigation was unable to determine a conclusive cause for the reported scaffold malapposition and patient effects.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.

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.

• 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: 6195304
• MDR Text Key: 63002268
• Report Number: 2024168-2016-09112
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212901
• UDI-Public: (01)08717648212901(17)170413(10)6041461
• 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
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2017
• Device Catalogue Number: 1234350-28
• Device Lot Number: 6041461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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): Hospitalization; Required Intervention