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

Catalog Number 1235250-12

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)

Patient Problems Embolism (1829); High Blood Pressure/ Hypertension (1908); Stenosis (2263); Foreign Body In Patient (2687)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a perforation in the left renal artery.The patient presented with hypertension; therefore, balloon angioplasty was performed on (b)(6) 2015 with a 2.5 x 8 mm and a 2.75 x 12 mm trek balloon dilatation catheter (bdc).Additionally, a 2.5 x 12 mm absorb gt1 scaffold was implanted in the lesion.Then, on (b)(6) 2016, the patient was re-hospitalized for persistent hypertension and an ultrasound revealed a narrowing in the left renal artery.It was also noted that the proximal portion of the absorb gt1 scaffold had fractured and embolized into the abdominal aorta.The remaining portion of the implanted scaffold was post-dilated with a 2.75 x 12 mm nc trek bdc, and it was noted that there was no waist.Attempts were then made to advance an intravascular ultrasound probe in the lesion; however, this device caused the remaining portion of the implanted absorb gt1 scaffold to embolize distally into the left lower part of the renal artery.On (b)(6) 2017, the patient was re-hospitalized and balloon angioplasty was performed in the lesion.Then, on (b)(6) 2018, an unspecified.014 grand slam guide wire was advanced and balloon angioplasty was performed with non-abbott bdcs and cutting balloons.The last post-dilatation of a non-abbott bdc caused a perforation in the lesion which was treated with a 2.8 x 16 mm graftmaster covered stent, which was inflated at 22 atmospheres.The perforation was sealed and a portion of the stent protrudes into the aorta without causing obstruction.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The reported patient effects of embolism, hypertension and restenosis, as listed in the absorb gt1 instructions for use (electronic instructions for use (ifu), are known adverse events associated with the use of a coronary scaffold in native coronary arteries.The investigation was unable to determine a conclusive cause for the reported scaffold fracture and patient effects.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.

• 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: 7822469
• MDR Text Key: 118421595
• Report Number: 2024168-2018-06656
• Device Sequence Number: 1
• Product Code: PNY
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1235250-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 21